Deknatel

Deklene II Clear Monofilament Polypropylene Size 5-0 18" HR 18X Needle

Registry build 21.09.26
3manufacturers in China registered for this device type
373catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Shandong (2), Beijing (1).

Chinese manufacturers registered for FDA product code GAW
Manufacturer City Province Registered as Device types
Shandong Haidike Medical Products Co., Ltd. Heze Shandong Manufacturer 22
Foosin Medical Supplies Inc.ltd Weihai Shandong Manufacturer 8
ARC Medical Supplies (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7

Record

Regulatory record for Deknatel
Listed by Teleflex Medical LLC, United States
FDA product code GAW
Device type Suture, Nonabsorbable, Synthetic, Polypropylene
Device class Class 2
Regulation 21 CFR 878.5010
Establishment Specification developer, Complaint-file establishment, Manufacturer
Record published 2015-10-16
Record revised 2025-01-16 (version 13)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: none
Packaging Box of 36, sleeve, box of 12, sleeve of 12, sleeve of 36, box of 6
Sizes Length 45 to 120 cm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Deknatel
Catalogue number Size Status
IPN011348 Length 75 cm In distribution
IPN011277 Length 75 cm In distribution
IPN011312 Length 60 cm In distribution
IPN049600 DEKLENE® II /Needle HR17+, HR17+ Size-4-0 In distribution
IPN927810 Length 75 cm In distribution
IPN011952 Length 60 cm In distribution
IPN011248 Length 45 cm In distribution
IPN011382 Length 60 cm In distribution
IPN029086 DEKLENE® II /Needle DLX24 Size-3-0 In distribution
IPN927804 Length 90 cm In distribution
IPN011387 DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0 In distribution
IPN011244 DEKLENE® MAXX™ /Needle AT-6, AT-6 Size-6-0 In distribution
IPN011333 Length 60 cm In distribution
IPN011902 DEKLENE® II /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011345 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN028917 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-7-0 In distribution
IPN049583 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN000845 Suture length 18″, Needle length.710″ In distribution
IPN011206 Length 90 cm In distribution
IPN011955 DEKLENE® II /Needle DS24 Size-4-0 In distribution
IPN927782 Length 90 cm In distribution
IPN011272 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-5-0 In distribution
IPN028981 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011960 Length 45 cm In distribution
IPN028954 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN029111 DEKLENE® II /Needle DSM10 Size-6-0 In distribution
IPN029112 DEKLENE® II /Needle DSM19 Size-4-0 In distribution
IPN011395 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011281 Length 75 cm In distribution
IPN927778 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011303 Length 120 cm In distribution
IPN028963 Length 75 cm In distribution
IPN028894 Length 90 cm In distribution
IPN927780 Length 90 cm In distribution
IPN011286 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011934 DEKLENE® II /Needle XT-6, XT-6 Size-6-0 In distribution
IPN029084 DEKLENE® II /Needle DLX13 Size-5-0 In distribution
IPN029101 DEKLENE® II /Needle XT-1 Size-6-0 In distribution
IPN011260 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN029082 DEKLENE® II /Needle DS18 Size-3-0 In distribution
IPN011931 Length 90 cm In distribution
IPN049597 DEKLENE® II /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011357 Length 90 cm In distribution
IPN028980 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN028993 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN029091 Length 45 cm In distribution
IPN927788 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN029161 Length 90 cm In distribution
IPN011195 Length 90 cm In distribution
IPN011360 DEKLENE® MAXX™ /Needle T-2, T-2 Size-5-0 In distribution
IPN028959 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-3-0 In distribution
IPN029085 DEKLENE® II /Needle DLX19 Size-4-0 In distribution
IPN011366 Length 75 cm In distribution
IPN011346 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN028984 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN028958 Length 90 cm In distribution
IPN011320 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN011947 DEKLENE® II /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN029106 DEKLENE® II /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN927800 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN011925 DEKLENE® II /Needle XT-1, XT-1 Size-5-0 In distribution
IPN029097 DEKLENE® II /Needle XT-6, XT-6 Size-6-0 In distribution
IPN011306 Length 60 cm In distribution
IPN028890 Length 90 cm In distribution
IPN011263 Length 120 cm In distribution
IPN011405 Length 60 cm In distribution
IPN011353 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN927826 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN011314 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN029088 DEKLENE® II /Needle DSM19 Size-3-0 In distribution
IPN011279 Length 90 cm In distribution
IPN029107 DEKLENE® II /Needle DS24 Size-4-0 In distribution
IPN011852 Length 75 cm In distribution
IPN011323 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN927793 Length 90 cm In distribution
IPN011875 DEKLENE® II /Needle DS18 Size-3-0 In distribution
IPN028987 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN028994 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN011324 DEKLENE® MAXX™ /Needle C-2, C-2 Size-3-0 In distribution
IPN011958 Length 45 cm In distribution
IPN029160 Length 90 cm In distribution
IPN927814 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN927813 Length 75 cm In distribution
IPN011198 Length 90 cm In distribution
IPN011883 Length 45 cm In distribution
IPN011927 DEKLENE® II /Needle XT-6, XT-6 Size-7-0 In distribution
IPN927784 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011278 Length 90 cm In distribution
IPN011383 Length 60 cm In distribution
IPN000844 Suture length 18″, Needle length.710″ In distribution
IPN028982 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011432 DEKLENE® MAXX™ /Needle T-10, T-10 Size-5-0 In distribution
IPN011335 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-5-0 In distribution
IPN011059 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN028989 Length 60 cm In distribution
IPN927801 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN028937 Length 60 cm In distribution
IPN927783 DEKLENE® MAXX™ /Needle C-2, C-2 Size-3-0 In distribution
IPN028951 Length 45 cm In distribution
IPN000845 Suture length 18″, Needle length.710″ In distribution
IPN927786 Length 45 cm In distribution
IPN000844 Suture length 18″, Needle length.710″ In distribution
IPN011879 DEKLENE® II /Needle DLX13 Size-5-0 In distribution
IPN011409 Length 60 cm In distribution
IPN011256 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-6-0 In distribution
IPN028931 DEKLENE® MAXX™ /Needle C-13, C-13 Size-2-0 In distribution
IPN011914 DEKLENE® II /Needle XT-6, XT-6 Size-7-0 In distribution
IPN011961 DEKLENE® II /Needle DSM19 Size-4-0 In distribution
IPN011201 DEKLENE® MAXX™ /Needle T-2, T-2 Size-4-0 In distribution
IPN011266 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-7-0 In distribution
IPN029000 DEKLENE® MAXX™ /Needle AT-6, AT-6 Size-5-0 In distribution
IPN011351 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011349 Length 45 cm In distribution
IPN011411 Length 60 cm In distribution
IPN011916 Length 90 cm In distribution
IPN028901 Length 90 cm In distribution
IPN011294 DEKLENE® MAXX™ /Needle T-2, T-2 Size-3-0 In distribution
IPN011339 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN011251 Length 75 cm In distribution
IPN012648 Length 90 cm In distribution
IPN011840 DEKLENE® II /Needle HR26+ Size-3-0 In distribution
IPN028957 Length 90 cm In distribution
IPN011938 DEKLENE® II /Needle HR12+, HR12+ Size-5-0 In distribution
IPN011401 Length 60 cm In distribution
IPN011393 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011193 Length 90 cm In distribution
IPN011298 DEKLENE® MAXX™ /Needle C-13, C-13 Size-2-0 In distribution
IPN011474 DEKLENE® MAXX™ /Needle AT-1, AT-1 Size-5-0 In distribution
IPN927818 Length 60 cm In distribution
IPN011197 Length 90 cm In distribution
IPN927832 Length 75 cm In distribution
IPN011944 Length 75 cm In distribution
IPN011950 DEKLENE® II /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN927812 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN011945 Length 60 cm In distribution
IPN029080 DEKLENE® II /Needle DS18 Size-3-0 In distribution
IPN927796 Length 60 cm In distribution
IPN011857 DEKLENE® II /Needle DSL16 Size-4-0 In distribution
IPN927803 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-5-0 In distribution
IPN049599 DEKLENE® II /Needle XT-6, XT-6 Size-7-0 In distribution
IPN011196 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011361 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-6-0 In distribution
IPN029099 DEKLENE® II /Needle XT-1, XT-1 Size-6-0 In distribution
IPN049578 DEKLENE® MAXX™ /Needle C-2, C-2 Size-3-0 In distribution
IPN049584 DEKLENE® MAXX™ /Needle T-2, T-2 Size-4-0 In distribution
IPN927817 DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0 In distribution
IPN011338 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-5-0 In distribution
IPN927805 Length 45 cm In distribution
IPN011397 Length 45 cm In distribution
IPN029104 DEKLENE® II /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011265 DEKLENE® MAXX™ /Needle C-2, C-2 Size-3-0 In distribution
IPN029095 DEKLENE® II /Needle HR17+, HR17+ Size-5-0 In distribution
IPN012378 Length 60 cm In distribution
IPN011880 DEKLENE® II /Needle DLX19 Size-4-0 In distribution
IPN028892 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN011208 DEKLENE® MAXX™ /Needle C-13, C-13 Size-3-0 In distribution
IPN927808 Length 75 cm In distribution
IPN011937 DEKLENE® II /Needle HR12, HR12 Size-6-0 In distribution
IPN011322 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN028905 Length 45 cm In distribution
IPN028962 Length 75 cm In distribution
IPN028991 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN011384 Length 75 cm In distribution
IPN011365 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN012647 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN927798 Length 60 cm In distribution
IPN029102 DEKLENE® II /Needle XT-1 Size-5-0 In distribution
IPN029100 DEKLENE® II /Needle XT-1, XT-1 Size-6-0 In distribution
IPN011261 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN927827 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN011300 DEKLENE® MAXX™ /Needle HR36+, HR36+ Size-3-0 In distribution
IPN011372 Length 90 cm In distribution
IPN011847 Length 45 cm In distribution
IPN927831 Length 60 cm In distribution
IPN011243 Length 75 cm In distribution
IPN011379 DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0 In distribution
IPN011301 DEKLENE® MAXX™ /Needle T-5V, T-5V Size-4-0 In distribution
IPN011267 Length 60 cm In distribution
IPN028974 DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0 In distribution
IPN011930 Length 90 cm In distribution
IPN029108 DEKLENE® II /Needle DS24 Size-3-0 In distribution
IPN028896 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-4-0 In distribution
IPN011426 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN028985 Length 60 cm In distribution
IPN029090 DEKLENE® II /Needle DLX40 Size-0 In distribution
IPN927822 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN029105 DEKLENE® II /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN927820 Length 45 cm In distribution
IPN029163 Length 90 cm In distribution
IPN011407 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN011959 Length 45 cm In distribution
IPN049596 DEKLENE® II /Needle HR22+, HR22+ Size-4-0 In distribution
IPN011191 DEKLENE® MAXX™ /Needle T-5, T-5 Size-4-0 In distribution
IPN049585 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011331 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-5-0 In distribution
IPN927836 Length 60 cm In distribution
IPN927830 Length 60 cm In distribution
IPN011903 Length 75 cm In distribution
IPN011468 DEKLENE® MAXX™ /Needle T-2, T-2 Size-4-0 In distribution
IPN011389 Length 60 cm In distribution
IPN927806 Length 75 cm In distribution
IPN028891 Length 75 cm In distribution
IPN011841 Length 75 cm In distribution
IPN011898 DEKLENE® II /Needle DSM13 Size-5-0 In distribution
IPN927787 Length 75 cm In distribution
IPN011343 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN012375 Length 60 cm In distribution
IPN927824 Length 60 cm In distribution
IPN028949 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-5-0 In distribution
IPN011268 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-7-0 In distribution
IPN029096 DEKLENE® II /Needle HR17+, HR17+ Size-3-0 In distribution
IPN927815 Length 90 cm In distribution
IPN029087 DEKLENE® II /Needle DSL13 Size-6-0 In distribution
IPN028920 Length 90 cm In distribution
IPN927825 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN011871 DEKLENE® II /Needle HRT26, HRT26 Size-2-0 In distribution
IPN011262 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN011318 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN029162 Length 90 cm In distribution
IPN011917 DEKLENE® II /Needle XT-1, XT-1 Size-5-0 In distribution
IPN011470 DEKLENE® MAXX™ /Needle C-2, C-2 Size-4-0 In distribution
IPN011850 Length 45 cm In distribution
IPN028930 Length 90 cm In distribution
IPN927790 Length 60 cm In distribution
IPN011275 DEKLENE® MAXX™ /Needle AT-2, AT-2 Size-5-0 In distribution
IPN011283 Length 45 cm In distribution
IPN028893 Length 90 cm In distribution
IPN028918 Length 60 cm In distribution
IPN011254 Length 60 cm In distribution
IPN011370 Length 90 cm In distribution
IPN927834 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN029078 DEKLENE® II /Needle XT-6 Size-7-0 In distribution
IPN011367 DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0 In distribution
IPN029089 DEKLENE® II /Needle DSM13 Size-5-0 In distribution
IPN029110 DEKLENE® II /Needle DS18 Size-5-0 In distribution
IPN011378 Length 75 cm In distribution
IPN927821 DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0 In distribution
IPN011204 DEKLENE® MAXX™ /Needle C-13, C-13 Size-4-0 In distribution
IPN029083 DEKLENE® II /Needle DLX30 Size-2-0 In distribution
IPN927833 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN927816 Length 75 cm In distribution
IPN927792 Length 90 cm In distribution
IPN011325 Length 90 cm In distribution
IPN028995 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0 In distribution
IPN028906 DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-8-0 In distribution
IPN028941 Length 60 cm In distribution
IPN011391 Length 45 cm In distribution
IPN927797 DEKLENE® MAXX™ /Needle XT-6, XT-6 Size-7-0 In distribution
IPN011890 DEKLENE® II /Needle DSM19 Size-3-0 In distribution
IPN011956 Length 45 cm In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DemeLENE Demetech Corp. 1,707
Premilene B Braun Surgical SA 1,247
Optilene B Braun Surgical SA 1,110
Prolene Ethicon, Inc. 765
Corolene® Peters Surgical 354
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle Foosin Medical Supplies Inc.ltd 346
Surgipro II Covidien LP 254
Surgipro ll Covidien LP 152
Atramat Internacional Farmacéutica S.A DE C.V 140
Surgipro Covidien LP 133
Filaprop Meril Endo Surgery PVT. Ltd. 123
Gore-TEX Suture W. L. Gore & Associates, Inc. 113

Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K193530 2020-03-19

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P890002 1989-05-31 POLYPROPYLENE SURGICAL SUTURE Alcon Laboratories, Inc.
P820083 1986-08-05 GORE-TEX(R) EXPANDED PTFE SUTURE W. L. Gore & Associates, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer