Sunmark
Catalogue number B FMDLS 0130 R02401 SM, listed by U.S. Cotton, LLC, under Fiber, Medical, Absorbent. 172 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (45), Zhejiang (30), Shanghai (20). 34 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 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jinhua Jingdi Medical Supplies Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 29 |
| Jinhua Ivy Home Textile Co., Limited | Jinhua | Zhejiang | Contract manufacturer | 18 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
Showing 12 of 172. All 172 manufacturers in China registered for Fiber, Medical, Absorbent
Record
| Listed by | U.S. Cotton, LLC |
|---|---|
| FDA product code | FRL |
| Device type | Fiber, Medical, Absorbent |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5300 |
| Premarket notification | Exempt |
| Record published | 2020-02-28 |
| Record revised | 2022-01-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Storage | Special storage condition: Store indoors under normal ambient conditions in sealed package |
| Packaging | Case of 24 |
| Distribution end date | 2022-01-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B FMDLS 0130 R02401 SM | 130 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Health Services, LLC | Novo Health Services, LLC | 172 |
| Curity | Cardinal Health | 75 |
| DeRoyal | Deroyal Industries, Inc. | 71 |
| Medline | Medline Industries, Inc. | 60 |
| A Plus | A Plus International, Inc | 58 |
| Cardinal Health | Cardinal Health 200, LLC | 47 |
| Bioseal Inc. | Bioseal | 44 |
| Airo™ CPAP Mask Liners | Athfar 828, Inc. | 37 |
| Curity | Cardinal Health 200, LLC | 31 |
| Medical Action / Manus | Medical Action Industries, Inc. | 31 |
| Medical Action Industries | Medical Action Industries, Inc. | 24 |
| Sofsorb OR Towel | Standard Textile Co., Inc. | 22 |
Showing 12 of 148. All products under Fiber, Medical, Absorbent
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.