| Primary Device ID | 07630055301826 |
| NIH Device Record Key | c483af0c-527a-40f0-b04e-54a1e061cf0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 30 DEGREE OFFSET ACETABULAR REAMER DRIVER BODY |
| Version Model Number | 481100570 |
| Catalog Number | 481100570 |
| Company DUNS | 485098284 |
| Company Name | Incipio Devices SA |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630055301826 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
[07630055301826]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 07630055301826 | Offset Acetabular Reamer Driver - body component accessory for use with 30° Offset Reamer Handl |
| 07630055306630 | Body accessory for Offset Reamer Handle |