Medline Industries, Inc.
Pencil,cautery,rocker,sterile,lf,ss
65manufacturers in China registered for this device type
68catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K964176 |
| Record published | 2023-07-29 |
| Record revised | 2023-07-26 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 50, case of 350, case of 200, case of 12, case of 250 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJZ05496 | In distribution | |
| DYNJ03097D | In distribution | |
| DYNJZ96402 | In distribution | |
| ESLAP7A | In distribution | |
| DYNJZ84880 | In distribution | |
| DYNJ67621 | In distribution | |
| DYNJZ27808 | In distribution | |
| DYNJX34716 | In distribution | |
| ESLAP5A | In distribution | |
| ESLAP11A | In distribution | |
| ESLAP16A | In distribution | |
| DYNJZ19279 | In distribution | |
| DYNJZ96401 | In distribution | |
| DYNJZ86185 | In distribution | |
| DYNJ50702 | In distribution | |
| DYNJZ24105 | In distribution | |
| DYNJZ86199 | In distribution | |
| DYNJZ126751 | In distribution | |
| DYNJZ26211 | In distribution | |
| DYNJZ119519 | In distribution | |
| DYND04173 | In distribution | |
| ESLAP4A | In distribution | |
| ESLAP14A | In distribution | |
| ESLAP10A | In distribution | |
| DYNJZALE14506 | In distribution | |
| ESLAP2A | In distribution | |
| CDS983645B | In distribution | |
| DYNJZ37716 | In distribution | |
| DYND04195 | In distribution | |
| DYNJZ86180 | In distribution | |
| DYNJZ89331 | In distribution | |
| ESLAP3A | In distribution | |
| DYNJZ07157 | In distribution | |
| DYNJZ96400 | In distribution | |
| ESRK3002L | In distribution | |
| DYNJZ23937 | In distribution | |
| DYNJX44131 | In distribution | |
| DYNJZ96404 | In distribution | |
| DYNJZ96403 | In distribution | |
| DYNJZ150625 | In distribution | |
| ESLAP8A | In distribution | |
| ESLAP15A | In distribution | |
| DYNJZ90078 | In distribution | |
| DYNJX05496A | In distribution | |
| DYNJZ36316 | In distribution | |
| ESLAP6A | In distribution | |
| DYNJZALE2350H | In distribution | |
| ESLAP13A | In distribution | |
| DYNJ51972 | In distribution | |
| DYNJZ11239 | In distribution | |
| DYNJZMEG0014M | In distribution | |
| DYNJZ84881 | In distribution | |
| ESRK3000 | In distribution | |
| ESLAP12A | In distribution | |
| ESLAP9A | In distribution | |
| DYNJZ12498 | In distribution | |
| DYNJZ126752 | In distribution | |
| ESLAP1A | In distribution | |
| DYNJZ10268 | In distribution | |
| DYNJ80258 | In distribution | |
| DYNJZ24176 | In distribution | |
| DYNJ65392 | In distribution | |
| DYNJZ86187 | In distribution | |
| DYNJZ86186 | In distribution | |
| DYNJ01209 | In distribution | |
| DYNJZ83499 | In distribution | |
| DYNJZMEG0012M | In distribution | |
| DYNJZ150597 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212093 | 2022-01-14 |
| K210526 | 2021-03-12 |
| K190643 | 2019-05-06 |
| K182812 | 2018-12-12 |
| K173889 | 2018-04-09 |
| K122949 | 2013-10-16 |
| K932654 | 1994-02-22 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| PSC Industries Inc | 510(k) number | 2012-06-01 | Class II | Labeling mix-ups | Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the ma | 80 units | 2015-09-15 |
| Megadyne Medical Products, Inc. | 510(k) number | 2009-10-13 | Not classified | Error in labeling | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. | 324 units | 2010-02-17 |
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.