Medline
Sterile Biopsy Drainage Pack
1manufacturer
37catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OFG |
| Device type | Ct Biopsy Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4075 |
| Premarket notification | Exempt |
| Record published | 2020-05-18 |
| Record revised | 2025-05-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, case of 20, pack of 30, pack of 10, case of 10, case of 35 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDH1264 | In distribution | |
| P809028 | In distribution | |
| SPEC0228 | In distribution | |
| DYNDH1580 | In distribution | |
| P365500 | In distribution | |
| SPEC0292 | In distribution | |
| SPEC0248B | In distribution | |
| SPEC0272 | In distribution | |
| DYNDH1254 | In distribution | |
| SPEC0295 | In distribution | |
| SPEC0186A | In distribution | |
| SPEC0117B | In distribution | |
| SPEC0083A | In distribution | |
| DYNDH1282 | In distribution | |
| P151659 | In distribution | |
| DYNDH1162 | In distribution | |
| SPEC0280 | In distribution | |
| SPEC0160A | In distribution | |
| SPEC0107D | In distribution | |
| SPEC0184 | In distribution | |
| SPEC0139B | In distribution | |
| P972300 | In distribution | |
| SPEC0145B | In distribution | |
| PHS861665002 | In distribution | |
| P751651 | In distribution | |
| SPEC0269B | In distribution | |
| SPEC0244B | In distribution | |
| SPEC0214A | In distribution | |
| P261569 | In distribution | |
| SPEC0252 | In distribution | |
| SPEC0149 | In distribution | |
| DYNDH1164 | In distribution | |
| DYNDH1481 | In distribution | |
| SPEC0240 | In distribution | |
| SPEC0125 | In distribution | |
| SPEC0261 | In distribution | |
| CT101 | 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 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 28 |
| ACS | American Contract Systems, Inc. | 11 |
| Centurion | Centurion Medical Products Corporation | 6 |
| DeRoyal | Deroyal Industries, Inc. | 1 |
| Halyard | Avid Medical, Inc. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 47185 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.