| Primary Device ID | 00811714036328 |
| NIH Device Record Key | 9343bc34-5bfe-427e-864c-56234b07e2f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Reusable Awl |
| Version Model Number | 285944 |
| Catalog Number | 285944 |
| Company DUNS | 002745858 |
| Company Name | RESPONSIVE ORTHOPEDICS LLC |
| 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 | false |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 00811714036328 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
[00811714036328]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 00811714035536 | 3.8 mm Reusable Awl |
| 00811714036328 | 3.8mm Reusable Awl |