Bioseal Inc.
Cervical Sleeve , 3mm Aperture
67manufacturers in China registered for this device type
38catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (26), Shanghai (11), Zhejiang (9). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | Hubei | Contract manufacturer | 13 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Jiangsu Xuhe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 9 |
| Nanjing HI-Tech Tape Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 67. All 67 manufacturers in China registered for Kit, Surgical Instrument, Disposable
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | KDD |
| Device type | Kit, Surgical Instrument, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 20, case of 10, case of 50, case of 25, case of 16, case of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17232/25 | In distribution | |
| 28854/10 | In distribution | |
| 17112/50 | In distribution | |
| 17177/20 | In distribution | |
| 19082/20 | In distribution | |
| 28855/10 | In distribution | |
| 17136/20 | In distribution | |
| 17171/10 | In distribution | |
| 17100/16 | In distribution | |
| 17130/20 | In distribution | |
| 17133/30 | In distribution | |
| 17170/10 | In distribution | |
| 21040/10 | In distribution | |
| 17137/20 | In distribution | |
| 481646-001 | In distribution | |
| 17472/20 | In distribution | |
| 17140/50 | In distribution | |
| 17160/50 | In distribution | |
| 24-685/20 | In distribution | |
| 17130/100 | In distribution | |
| 17172/10 | In distribution | |
| 017100/16 | In distribution | |
| 21060/05 | In distribution | |
| 17176/10 | In distribution | |
| 17134/20 | In distribution | |
| 17139/20 | In distribution | |
| 17135/20 | In distribution | |
| 190-0033-001 | In distribution | |
| 17150/50 | In distribution | |
| 17180/10 | In distribution | |
| 18296/24 | In distribution | |
| 21080/05 | In distribution | |
| 17175/20 | In distribution | |
| 18296/25 | In distribution | |
| 17138/20 | In distribution | |
| 017201/04 | In distribution | |
| 17132/50 | In distribution | |
| 28854CS/10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 789 |
| CustomEyes® | Beaver-Visitec International, Ltd | 696 |
| DeRoyal | Deroyal Industries, Inc. | 589 |
| Centurion | Centurion Medical Products Corporation | 277 |
| Readypak Kit | Beaver-Visitec International, Ltd | 196 |
| Custom Healthcare Systems, Inc. | Manus Medical, LLC | 78 |
| Medical Action Industries | Medical Action Industries, Inc. | 76 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 37 |
| In2Bones | IN2BONES USA, LLC | 24 |
| Aero-Med | Aero-MED LLC | 23 |
| Medline | Medline Industries, Inc. | 17 |
| McKesson | Mckesson Medical-Surgical Inc. | 17 |
Showing 12 of 252. All products under Kit, Surgical Instrument, Disposable
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-03-23 | Class II | Unknown/Undetermined by firm | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | 580 units |
| 2021-03-23 | Class II | Unknown/Undetermined by firm | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | 140 units |
| 2021-03-23 | Class II | Unknown/Undetermined by firm | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. | 1,560 units |
| 2017-10-18 | Class II | Nonconforming Material/Component | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. | 51635 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.