| Primary Device ID | B354IS349440 |
| NIH Device Record Key | 0416d326-0235-4859-97fa-c5da55b91ee6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Needle Holder Straight 44cm |
| Version Model Number | OS34944 |
| Company DUNS | 047063695 |
| Company Name | ORANGE SURGICAL INSTRUMENTS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B354IS349440 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
[B354IS349440]
Peracetic Acid
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-01 |
| Device Publish Date | 2024-01-24 |
| B354IS349440 | Needle Holder Straight 44cm |
| B354OS349440 | Needle Holder Straight 44cm |