E.M Adams Co., Inc.
Suture Removal Tray
12manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (2), Hubei (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Excellent Medical Technology Co., Ltd. | Hong Kong | Hong Kong | Specification developer | 17 |
Record
| Listed by | E.M. Adams Co., Inc., United States |
|---|---|
| FDA product code | MCZ |
| Device type | Suture Removal Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| 510(k) | K812132 |
| Record published | 2019-12-31 |
| Record revised | 2021-03-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100, case of 200 |
| Distribution end date | 2021-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 114-2175-1 | 6″ X 3.75″ X 5″ | In distribution |
| 14-70802-1 | 6″ x 3.75 x.5 | In distribution |
| 114-2062-1 | 6″ X 3.75″ X 5″ | In distribution |
| 14-70804-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70814-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70809JK-1 | 6″ X 3.75″ X.5″ | In distribution |
| 14-70831-1 | 6″ x 3.75 x.5 | In distribution |
| 114-2076-1 | 6″ X 3.75″ X 5″ | In distribution |
| 14-70844-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70845-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70821-1 | 6″ x 3.75 x.5 | In distribution |
| 114-2212-1 | 6″ X 3.75″ X 5″ | In distribution |
| 14-70811-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70819-1 | 6″ x 3.75 x.5 | In distribution |
| 114-239-1 | 6″ X 3.75″ X 5″ | In distribution |
| 114-2033-1 | 6″X3.75″X5″ | In distribution |
| 14-70862-1 | 6″ x 3.75 x.5 | In distribution |
| 14-70844-1 | 6″ x 3.75 x.5 | Withdrawn |
| 114-2062-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 14-70804-1 | 6″ x 3.75 x.5 | Withdrawn |
| 14-70845-1 | 6″ x 3.75 x.5 | Withdrawn |
| 14-70811-1 | 6″ x 3.75 x.5 | Withdrawn |
| 114-239-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 114-2076-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 14-70831-1 | 6″ x 3.75 x.5 | Withdrawn |
| 114-2175-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 14-70814-1 | 6″ x 3.75 x.5 | Withdrawn |
| 14-70862-1 | 6″ x 3.75 x.5 | Withdrawn |
| 14-70821-1 | 6″ x 3.75 x.5 | Withdrawn |
| 114-2212-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 14-70802-1 | 6″ x 3.75 x.5 | Withdrawn |
| 114-2033-1 | 6″X3.75″X5″ | Withdrawn |
| 14-70819-1 | 6″ x 3.75 x.5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 166 |
| Medical Action Industries | Medical Action Industries, Inc. | 99 |
| Centurion | Centurion Medical Products Corporation | 71 |
| Medline Industries, Inc. | Medline Industries, Inc. | 48 |
| LSL Healthcare | Lsl Industries, Inc. | 42 |
| Medline | Medline Industries, Inc. | 42 |
| Novaplus® | Medical Action Industries, Inc. | 16 |
| McKesson | Mckesson Medical-Surgical Inc. | 11 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 10 |
| Stradis Healthcare | Stradis Healthcare | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 8 |
| MediChoice | Owens & Minor Distribution, Inc. | 8 |
Showing 12 of 35. All products under Suture Removal Kit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K812132 | 1981-12-01 |
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.