Primary Device ID | 10714646001129 |
NIH Device Record Key | 2a9a7a56-36bd-4a13-bfc1-74bfa1f24d7a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sample: Opti-Tatt |
Version Model Number | 24100 |
Catalog Number | 24100 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 6 |
DM Exempt | false |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00714646001122 [Primary] |
GS1 | 10714646001129 [Unit of Use] |
FZZ | MARKER, SKIN |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-30 |
Device Publish Date | 2025-06-20 |
10714646001129 - Sample: Opti-Tatt | 2025-06-30Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border |
10714646001129 - Sample: Opti-Tatt | 2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border |
00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement | 2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement |
00714646001399 - Prone Breast, Face Cushion, Replacement | 2025-06-05 Prone Breast, Face Cushion, Replacement |
00714646001405 - Prone Breast, Arm Rest, Replacement | 2025-06-05 Prone Breast, Arm Rest, Replacement |
00714646001412 - Prone Breast, Leg Cushion, Replacement | 2025-06-05 Prone Breast, Leg Cushion, Replacement |
00714646001429 - Prone Breast, Hand Post Assembly, Replacement | 2025-06-05 Prone Breast, Hand Post Assembly, Replacement |
00714646001436 - Prone Breast, Hardware Kit, Threaded Indexing Pegs | 2025-06-05 Prone Breast, Hardware Kit, Threaded Indexing Pegs |
00714646001443 - Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement | 2025-06-05 Prone Breast, Hardware Kit, Head Rest Push Button Assembly, Replacement |