Sklar®

Censitrac Ready Dennis Anastomosis Clamp LG 9 Inches

Registry build 21.09.26
27manufacturers in China registered for this device type
2,052catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (7), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEN
Manufacturer City Province Registered as Device types
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Zhejiang Shuyou Surgical Instrument Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Zhejiang Tiansong Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 4
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Planet(Shanghai) International Co., Ltd. Shanghai Shanghai Exporter 93
Planet (Anhui) International Co., Ltd. Chuzhou Anhui Exporter 80
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Showing 12 of 27. All 27 manufacturers in China registered for Forceps, General & Plastic Surgery

Record

Regulatory record for Sklar®
Listed by Sklar Corporation, United States
FDA product code GEN
Device type Forceps, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-12-07
Record revised 2019-08-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar®
Catalogue number Size Per pack Status
47-1172 In distribution
47-2047 In distribution
52-6686 In distribution
36-2790 In distribution
17-2550 In distribution
47-1173C In distribution
19-2314 In distribution
50-2670 In distribution
19-1455C In distribution
19-1945 In distribution
17-1450C In distribution
23-2809C In distribution
97-795 In distribution
61-0108 In distribution
23-2840 In distribution
17-1235C In distribution
23-2600C In distribution
55-2237 In distribution
36-2890C In distribution
21-477 12 In distribution
52-1522 In distribution
51-4353 In distribution
55-2894 In distribution
19-2050 In distribution
21-449 12 In distribution
40-4269 In distribution
22-6970C In distribution
17-2467 In distribution
67-1040C In distribution
98-4352 In distribution
47-3516 In distribution
51-4416 In distribution
40-2681 In distribution
90-2720 In distribution
19-1985 In distribution
36-2662 In distribution
36-3606 In distribution
14-2496 In distribution
67-1045C In distribution
36-1701 In distribution
55-2048 In distribution
22-3855 In distribution
17-1262C In distribution
23-2838 In distribution
32-2266 In distribution
97-521 In distribution
51-4220 In distribution
17-2055 In distribution
98-2010 In distribution
14-2493 In distribution
96-2289M 25 In distribution
19-2948 In distribution
55-2892C In distribution
51-4370C In distribution
21-710 12 In distribution
96-2351 25 In distribution
55-2452 In distribution
21-515 12 In distribution
55-2112C In distribution
19-2945 In distribution
30807 In distribution
40-2275 In distribution
17-2960C In distribution
17-3055 In distribution
21-285 12 In distribution
97-603 In distribution
97-775 In distribution
36-1710 In distribution
36-4311 In distribution
55-2220 In distribution
21-608 12 In distribution
47-3533 In distribution
10-1081 In distribution
19-2860 In distribution
40-2708 In distribution
47-1122 In distribution
61-0110 In distribution
40-2485 In distribution
55-2880 In distribution
19-1916 In distribution
51-4382 In distribution
33-1004 In distribution
50-1472 In distribution
19-2260C In distribution
33-1001C In distribution
22-3270 In distribution
98-4117T In distribution
95-514 In distribution
40-8400 In distribution
50-1369 In distribution
40-2600 In distribution
17-3996 In distribution
36-2660 In distribution
55-2049 In distribution
21-593 12 In distribution
40-2685 In distribution
67-1152 In distribution
19-1480C In distribution
55-2329 In distribution
55-2775 In distribution
19-1341 In distribution
19-1922 In distribution
97-501 In distribution
40-4246 In distribution
52-1415 In distribution
52-1430 In distribution
19-1343 In distribution
52-1531 In distribution
19-2320 In distribution
96-2299 25 In distribution
40-2845 In distribution
40-2607 In distribution
36-1860 In distribution
19-1050 In distribution
32-2470 In distribution
36-4320 In distribution
36-2810 In distribution
40-2605 In distribution
36-2710C In distribution
96-2463M 25 In distribution
21-492 12 In distribution
17-2762 In distribution
51-3480 In distribution
96-2922 100 In distribution
98-7740 In distribution
95-465 In distribution
23-2521 In distribution
51-1446 In distribution
98-9214 In distribution
21-920 12 In distribution
17-3670 In distribution
31991 In distribution
60-7219 In distribution
21-232 12 In distribution
47-3520 In distribution
96-2907 100 In distribution
19-1975 In distribution
21-124 12 In distribution
15-1357 In distribution
19-1352 In distribution
52-4260 In distribution
61-0101 In distribution
61-2111 In distribution
21-465 12 In distribution
67-1035C In distribution
98-7704 In distribution
36-2280C In distribution
21-227 12 In distribution
55-2870 In distribution
97-589 In distribution
97-494 In distribution
40-7175 In distribution
52-1523 In distribution
67-1732 In distribution
40-2420 In distribution
95-500 In distribution
47-1180C In distribution
95-447 In distribution
36-2298 In distribution
47-1175 In distribution
51-4234 In distribution
23-2513 In distribution
17-3375C In distribution
98-4357 In distribution
97-436 In distribution
33-1001 In distribution
95-426 In distribution
67-1150C In distribution
55-2762 In distribution
17-1255 In distribution
40-2706 In distribution
51-3032 In distribution
23-2864 In distribution
19-3035C In distribution
98-123 In distribution
96-2556M 25 In distribution
96-2295M 25 In distribution
36-2880 In distribution
21-795 12 In distribution
96-2550M 50 In distribution
50-1574 In distribution
19-1445 In distribution
95-577 In distribution
23-2845 In distribution
21-478 12 In distribution
23-2510 In distribution
18-2052C In distribution
17-3210 In distribution
98-232 In distribution
95-466 In distribution
47-3537 In distribution
47-3555 In distribution
97-504 In distribution
36-2812C In distribution
67-1250 In distribution
17-1460 In distribution
55-2820 In distribution
67-1450 In distribution
98-4253T In distribution
22-4470 In distribution
18-1852C In distribution
23-2861 In distribution
17-3660 In distribution
95-442 In distribution
21-764 12 In distribution
96-2624M 25 In distribution
52-1545 In distribution
32-2065 In distribution
40-2422 In distribution
17-1162 In distribution
52-1551 In distribution
55-2894C In distribution
17-2885 In distribution
95-727 In distribution
21-481 12 In distribution
90-7999 In distribution
51-4420 In distribution
52-1519 In distribution
21-224 12 In distribution
22-4550 In distribution
22-3452C In distribution
36-2712 In distribution
22-6457 In distribution
07-1797C In distribution
40-2413 In distribution
47-3510 In distribution
47-3512 In distribution
19-3056 In distribution
17-1276 In distribution
55-2898 In distribution
97-512 In distribution
52-1461 In distribution
32-2095 In distribution
40-2842 In distribution
52-1552 In distribution
17-2960 In distribution
19-1480 In distribution
61-1106 In distribution
36-2790C In distribution
55-2324 In distribution
17-1424 In distribution
97-431 In distribution
17-2678 In distribution
40-4225 In distribution
17-1772 In distribution
17-3458 In distribution
19-2040 In distribution
51-4412 In distribution
50-3046 In distribution
19-2182 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surtex Surtex Instruments Ltd 1,613
Millennium Avalign Technologies, Inc. 1,238
Ambler Surgical Ambler Surgical, LLC 1,163
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 1,020
Surgical Direct Surgical Direct, Inc. 857
Novo Surgical Novo Surgical, Inc. 603
Peak Medical Peak Medical Distribution Inc 598
Novo Surgical Inc. Novo Surgical, Inc. 598
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 582
Forceps KLS-Martin L.P. 577
Boss Instruments Boss Instruments, Ltd. 543
Assi Accurate Surgical & Scientific Instruments Corp. 472

Showing 12 of 751. All products under Forceps, General & Plastic Surgery

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Sklar®
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Sklar Corporation UDI-DI 2024-12-03 Class II Under Investigation by firm Reports of various packaging issues that may result in a breach of the sterile barrier. 245015 units

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