| Primary Device ID | 10630094013487 |
| NIH Device Record Key | bea31677-99e8-4857-b8f5-5b087e374df6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioseal Inc. |
| Version Model Number | 1348/25 |
| Company DUNS | 186968939 |
| Company Name | BIOSEAL |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630094013480 [Primary] |
| GS1 | 10630094013487 [Package] Contains: 00630094013480 Package: Case [25 Units] In Commercial Distribution |
| PUI | Drape, surgical, exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-13 |
| Device Publish Date | 2020-02-05 |
| 10630094299034 | Vaginal Speculum Large |
| 10630094299027 | Vaginal Speculum Medium |
| 10630094291014 | Vaginal Speculum Fiber Optic Med Wrapped |
| 10630094103188 | Vaginal Speculum Fiber Optic Large w/ Sheath |
| 10630094102181 | Vaginal Speculum Fiber Optic Medium w/ Sheath |
| 10630094101184 | Vaginal Speculum Fiber Optic Small w/ Sheath |
| 10630094970056 | Vaginal Speculum w/ Sheath |
| 10630094910137 | Vaginal Speculum Fiber Optic Large |
| 10630094689019 | Vaginal Speculum Clear w/ Light Wrapped |
| 10630094910113 | Vaginal Speculum Fiber Optic Small |
| 10630094298075 | Vaginal Speculum Clear Large, Light Source |
| 10630094298051 | Vaginal Speculum Clear Medium, Light Source |
| 10630094298020 | Vaginal Speculum Clear Small, Light Source |
| 10630094298013 | Vaginal Speculum Clear X-Small, Light Source |
| 10630094012312 | Stockinette Tubular 3"x36" 1ply |
| 10630094012251 | Stockinette Tubular 2"x25" 1ply |
| 10630094012213 | Stockinette Tubular 2"x36" 1ply |
| 10630094012183 | Stockinette Tubular 2"x18" Single Ply |
| 10630094012619 | Stockinette Tubular 6"x36" 1ply |
| 10630094012602 | Stockinette Tubular 6"x60" 1ply |
| 10630094012497 | Stockinette Tubular 4"x18" 1ply |
| 10630094012480 | Stockinette Tubular 4"x48" 1ply |
| 10630094012411 | Stockinette Tubular 4"x36" 1ply |
| 10630094012404 | Stockinette Tubular 4"x60" 1ply |
| 10630094012688 | Stockinette Tubular 6"x48" 1ply |
| 10630094012657 | Stockinette Tubular 6"x25" 1ply |
| 10630094012626 | Stockinette Tubular 6"x72" 1ply |
| 10630094012695 | Stockinette Tubular 6"x18" 1ply |
| 10630094013326 | Stockinette Tubular 3"x36" 2ply CSR Wrapped |
| 10630094013319 | Stockinette Tubular 3"x36" 2ply |
| 10630094013227 | Stockinette Tubular 2"x72" 2ply |
| 10630094013203 | Stockinette Tubular 2"x30" 2ply |
| 10630094012886 | Stockinette Tubular 8"x48" 1ply |
| 10630094013418 | Stockinette Tubular 4"x36" 2ply |
| 10630094013401 | Stockinette Tubular 4"x60" 2ply |
| 10630094013388 | Stockinette Tubular 3"x48" 2ply |
| 10630094013876 | Stockinette Tubular 8"x52" 2ply |
| 10630094013821 | Stockinette Tubular 8"x72" 2ply |
| 10630094013807 | Stockinette Tubular 8"x60" 2ply |
| 10630094013760 | Stockinette Tubular 6"x60" 2ply Folded |
| 10630094013685 | Stockinette Tubular 6"x48" 2ply |
| 10630094013661 | Stockinette Tubular 6"x40" 2ply |
| 10630094013623 | Stockinette Tubular 6"x72" 2ply |
| 10630094013609 | Stockinette Tubular 6"x60" 2ply |
| 10630094013494 | Stockinette Tubular 4"x48" 2ply CSR Wrapped |
| 10630094013487 | Stockinette Tubular 4"x48" 2ply |
| 10630094013456 | Stockinette Tubular 4"x20" 2ply |
| 10630094013425 | Stockinette Tubular 4"x72" 2ply |
| 10630094126064 | Stockinette Tubular 6"x60" 1ply CSR Wrapped |
| 10630094124855 | Stockinette Tubular 4"x48" 1ply CSR Wrapped |