Bioseal Inc.
- Primary DI
- 10630094024124
- Brand
- Bioseal Inc.
- Company
- BIOSEAL
- Model
- 2412L/25
- Device description
- Packing Gauze X-Ray Detectable
- Published
- 2023-12-21
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| GDY | Gauze/sponge, internal, x-ray detectable |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10630094024124 | Package | GS1 | 25 | In Commercial Distribution |
| 00630094024127 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10630094024124 | 10630094024124 | ||
| 00630094024127 | 00630094024127 | 630094024127 | 0630094024127 |
GMDN Terms
| 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. |
Sterilization Methods
| Method |
|---|
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
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00630094481029 | Bioseal Inc. | DURA102/100 | 2025-05-29 | |
| 00630094481234 | Bioseal Inc. | DURA123/100 | 2025-05-29 | |
| 00630094483009 | Bioseal Inc. | DURA300/100 | 2025-05-29 | |
| 00630094485058 | Bioseal Inc. | DURA505/100 | 2025-05-29 | |
| 00630094485126 | Bioseal Inc. | DURA512/100 | 2025-05-29 | |
| 00630094487021 | Bioseal Inc. | DURA702/100 | 2025-05-29 | |
| 00630094487052 | Bioseal Inc. | DURA705/100 | 2025-05-29 | |
| 00630094487304 | Bioseal Inc. | DURA730/100 | 2025-05-29 | |
| 00630094489025 | Bioseal Inc. | DURA902/100 | 2025-05-29 | |
| 00630094480503 | Bioseal Inc. | DURA050/100 | 2025-05-28 | |
| 10630094292240 | Bioseal Inc. | 32-922-4/20 | 2024-01-10 | |
| 10630094335404 | Bioseal Inc. | 33-540/20 | 2024-01-10 | |
| 10630094055111 | Bioseal Inc. | 551S/20 | 2024-01-29 | |
| 10630094055135 | Bioseal Inc. | 551L/20 | 2024-01-29 | |
| 10630094055142 | Bioseal Inc. | 551M/20 | 2024-01-29 | |
| 10630094055197 | Bioseal Inc. | 551R/20 | 2024-01-29 | |
| 10630094061501 | Bioseal Inc. | 6150/25 | 2024-01-29 | |
| 10630094061518 | Bioseal Inc. | 6151/25 | 2024-01-29 | |
| 10630094061525 | Bioseal Inc. | 6152/50 | 2024-01-29 | |
| 10630094064243 | Bioseal Inc. | 6424/120 | 2024-01-29 |
Other Devices Sharing Product Codes
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|---|---|---|---|---|
| 50192253050293 | Vistec | Cardinal Health 200, LLC | GDY | 2026-03-05 |
| 10815555025678 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025685 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025661 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025630 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025623 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025647 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 10815555025654 | Cypress | MCKESSON MEDICAL-SURGICAL INC. | GDY | 2025-12-16 |
| 50198956239690 | CARDINAL HEALTH | Cardinal Health 200, LLC | GDY | 2025-11-28 |
| 10850049994863 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994870 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994887 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994894 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994900 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994917 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994924 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994931 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994948 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994955 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994962 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994979 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-26 |
| 10850049994993 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-23 |
| 10850049994986 | Syntervention | ZIEN MEDICAL TECHNOLOGIES, INC. | GDY | 2025-09-22 |
| 37613327465854 | SurgiCount Safety-Sponge | STRYKER CORPORATION | GDY | 2025-09-03 |
| 06979032640079 | GOBEN | HUZHOU JUNDA INDUSTRY CO., LTD. | GDY | 2025-08-26 |
| 30193489015991 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-06-12 |
| 40888277338914 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-06-06 |
| 40193489079747 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-06-06 |
| 40193489079754 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-06-06 |
| 40193489079822 | MEDLINE | MEDLINE INDUSTRIES, INC. | GDY | 2025-06-06 |