Invenio
LACERATION PACK_Sterile_36EA/CS
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | GRI Medical & Electronic Technology Co., Ltd., China |
|---|---|
| FDA product code | PKD |
| Device type | Laceration Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4014 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-10-27 |
| Record revised | 2024-09-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HMH010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 164 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 67 |
| Cardinal Health | Cardinal Health 200, LLC | 64 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 8 |
| Stradis Healthcare | Stradis Healthcare | 7 |
| Centurion | Centurion Medical Products Corporation | 4 |
| MediChoice | Owens & Minor Distribution, Inc. | 1 |
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.