Bioseal Inc.
Robotic Surgery Count Sheet
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Dongguan Linghui Optoelectronic Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | LYV |
| Device type | Label Or Tag, Sterile |
| 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 50, case of 20, case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17121/50 | In distribution | |
| 18881/20 | In distribution | |
| 17130NS/25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Centurion | Centurion Medical Products Corporation | 979 |
| Medline Industries, Inc. | Medline Industries, Inc. | 261 |
| PharmaTags | Rmac Surgical Inc | 105 |
| Medimark Sheet Tape | Sontec Instruments, Inc. | 74 |
| E-Z ID Rings | Zirc Dental Products, Inc. | 59 |
| E-Z ID Tape | Zirc Dental Products, Inc. | 32 |
| Key Surgical Sterile Labels | Key Surgical, LLC | 25 |
| PAL™ | Merit Medical Systems, Inc. | 21 |
| Cygnus | Aspen Surgical Products, Inc. | 20 |
| Sterile Labels | Key Surgical, LLC | 12 |
| Label Or Tag, Sterile | Key Surgical, LLC | 12 |
| Richard-Allan® Utility Marker with Labels | Aspen Surgical Products, Inc. | 11 |
Showing 12 of 2,086. All products under Label Or Tag, Sterile
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.