Bioseal Inc.
- Primary DI
- 10630094022021
- Brand
- Bioseal Inc.
- Company
- BIOSEAL
- Model
- 2202/25
- Device description
- Packing Gauze X-Ray Detectable
- Published
- 2023-12-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| GDY | Gauze/sponge, internal, x-ray detectable |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10630094022021 | Package | GS1 | 25 | In Commercial Distribution |
| 00630094022024 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10630094022021 | 10630094022021 | | |
| 00630094022024 | 00630094022024 | 630094022024 | 0630094022024 |
GMDN Terms#
Term, Definition table| Term | Definition |
|---|
| Gauze packer | A hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device. |
Regulatory Flags#
- DUNS number
- 186968939
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 10198956239692 | CARDINAL HEALTH | Cardinal Health 200, LLC | GDY | 2025-11-28 |
| 07613327465853 | SurgiCount Safety-Sponge | STRYKER CORPORATION | GDY | 2025-09-03 |
| 10080196717811 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-04-25 |
| 10197106760994 | CARDINAL HEALTH | Cardinal Health 200, LLC | GDY | 2025-01-29 |
| 10080196031313 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-01-16 |
| 10080196743926 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2024-10-15 |
| 10326053119504 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119511 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119528 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119535 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119542 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119559 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119566 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119573 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 10326053119580 | Regard™ | Resource Optimization & Innovation, L.L.C. | GDY | 2023-08-09 |
| 08600036785272 | USMEDCO | US MEDCO INC | GDY | 2023-07-14 |
| 08600036785340 | USMEDCO | US MEDCO INC | GDY | 2023-07-14 |
| 08600036785418 | USMEDCO | US MEDCO INC | GDY | 2023-07-14 |
| 08600036785586 | USMEDCO | US MEDCO INC | GDY | 2023-07-14 |
| 08600036785654 | USMEDCO | US MEDCO INC | GDY | 2023-07-14 |
| 10197106046968 | CARDINAL HEALTH | Cardinal Health 200, LLC | GDY | 2023-07-12 |
| 10192253050288 | Kerlix | Cardinal Health 200, LLC | GDY | 2023-03-24 |
| 10665973000012 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000029 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000036 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000050 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000067 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000081 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000098 | Dukal | Dukal LLC | GDY | 2022-12-06 |
| 10665973000166 | Dukal | Dukal LLC | GDY | 2022-12-06 |