GIA Premium
3 catalogue numbers from 030470, listed by Covidien LP, United States, under Apparatus, Suturing, Stomach And Intestinal. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | FHM |
| Device type | Apparatus, Suturing, Stomach And Intestinal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| 510(k) | K801590 |
| Record published | 2018-08-10 |
| Record revised | 2025-11-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 6 |
| Sizes | Length 50 to 90 mm; height 3.8 mm |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 030470 | Length 50 mm | In distribution |
| 030424L | Length 50 mm | Withdrawn |
| 030735L | Height 3.8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TA Premium | Covidien LP | 3 |
| Para-Pak Clean | Meridian Bioscience, Inc. | 1 |
| TA 90 BN | Covidien LP | 1 |
| Premium Multifire TA | Covidien LP | 1 |
| Pro-Flo™ | Medtronic, 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.