| Primary Device ID | D9289101400 |
| NIH Device Record Key | a2200a5a-5b48-4105-876b-0563438a4e84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IVRO RETRACTOR, TWO PIECES |
| Version Model Number | 91-0140 |
| 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 | D9289101400 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
[D9289101400]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-02 |
| Device Publish Date | 2025-04-24 |