Axiom® Lig-A-Loops®
Retraction Tape, Maxi, Yellow, Ureters
45manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (11), Shanghai (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 6 |
| Shanghai Kohope Medical Devices Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 45. All 45 manufacturers in China registered for Instrument, Surgical, Disposable
Record
| Listed by | Axiom Medical, Inc., United States |
|---|---|
| FDA product code | KDC |
| Device type | Instrument, Surgical, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| 510(k) | K800015 |
| Record published | 2018-09-23 |
| Record revised | 2019-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 60, case of 10, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115 | In distribution | |
| 117 | In distribution | |
| 113 | In distribution | |
| 114 | In distribution | |
| 118 | In distribution | |
| 112 | In distribution | |
| 111 | In distribution | |
| 116 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 213 |
| DeRoyal | Deroyal Industries, Inc. | 167 |
| Medical Action Industries | Medical Action Industries, Inc. | 112 |
| Centurion | Centurion Medical Products Corporation | 98 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 77 |
| Sterion® Vessel Loop | Aspen Surgical Products, Inc. | 47 |
| Sterion®Clamp Cover Fabric | Aspen Surgical Products, Inc. | 31 |
| Integra | Provision | 26 |
| Devon | Cardinal Health | 25 |
| Instrument, Surgical, Disposable | Summit Medical LLC | 23 |
| Dermapac, Inc. | Dermapac Inc. | 22 |
| CareFusion 2200 | Provision | 20 |
Showing 12 of 155. All products under Instrument, Surgical, Disposable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K820161 | 1982-03-15 |
| K800015 | 1980-03-25 |
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.