ACS
Biopsy/Minor Procedure Pack
1manufacturer
11catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | OFG |
| Device type | Ct Biopsy Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4075 |
| Premarket notification | Exempt |
| Record published | 2023-07-14 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVRB12A | In distribution | |
| SGBP16B | In distribution | |
| SGBP16D | In distribution | |
| LLCT16I | In distribution | |
| AMCT10A | In distribution | |
| EVRB12C | In distribution | |
| WHCT10F | In distribution | |
| SGBP16C | In distribution | |
| SGBP16A | In distribution | |
| EVRB12B | In distribution | |
| LLCT16J | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,252 |
| Cardinal Health | Cardinal Health 200, LLC | 315 |
| Medline | Medline Industries, Inc. | 37 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 28 |
| Centurion | Centurion Medical Products Corporation | 6 |
| DeRoyal | Deroyal Industries, Inc. | 1 |
| Halyard | Avid Medical, 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.