Primary Device ID | 10630094335404 |
NIH Device Record Key | e23ddcb3-3b17-4c5a-a7fc-3707a92c60ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bioseal Inc. |
Version Model Number | 33-540/20 |
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 | 00630094335407 [Primary] |
GS1 | 10630094335404 [Package] Contains: 00630094335407 Package: Case [20 Units] In Commercial Distribution |
KDC | INSTRUMENT, SURGICAL, DISPOSABLE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-11-25 |
Device Publish Date | 2024-01-10 |
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 |