| Primary Device ID | 04058935011604 |
| NIH Device Record Key | 84c15cd1-c281-450d-9b0e-ac0d35676bec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barraquer Needle Holder, Straight |
| Version Model Number | E3828 SW |
| Company DUNS | 344609518 |
| Company Name | Bausch & Lomb GmbH |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 | 04058935011604 [Primary] |
| HNM | Needle, Ophthalmic Suturing |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
[04058935011604]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 04058935011611 | E3828 SWO |
| 04058935011604 | E3828 SW |