| Primary Device ID | D928200058LEM0 |
| NIH Device Record Key | 51f088cc-c64d-47b2-8c9a-3d862189a08a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RETRACTOR UP 12 X 55, TAPERED TIP 3MM NOTCH |
| Version Model Number | 20-0058LEM |
| Company DUNS | 183854322 |
| Company Name | W.H. Holden, Inc. |
| 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 | 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 |
|---|---|
| HIBCC | D928200058LEM0 [Primary] |
| EIG | Retractor, All Types |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
[D928200058LEM0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-29 |
| Device Publish Date | 2025-05-21 |