Medline Industries, Inc.
ON OFF KIT #IMF 81512
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FSH |
| Device type | Tray, Surgical, Needle |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2018-08-28 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYKM1512 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jamshidi | Carefusion 2200, Inc. | 13 |
| Tray, Surgical, Needle | Carefusion 2200, Inc. | 6 |
| Inhance | Depuy (Ireland) | 2 |
| Inhance Intact | Depuy (Ireland) | 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.