| Primary Device ID | 07630055306814 |
| NIH Device Record Key | d54d28dd-290a-4d85-90c3-2782f962541f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Offset reamer handle - Body |
| Version Model Number | 131-174/02 |
| Catalog Number | 50244505 |
| 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 | 07630055306814 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
[07630055306814]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-18 |
| Device Publish Date | 2026-03-10 |
| 07630055304483 | Offset Reamer Handle body accessory |
| 07630055304599 | Offset Reamer Handle body accessory |
| 07630055304896 | Body accessory for offset reamer handles |
| 07630055302632 | Body accessory for offset reamer handles |
| 07630055305206 | Body accessory for offset reamer handles |
| 07630055305923 | Body accessory for Offset Reamer Handle |
| 07630055306814 | Body accessory for Offset Reamer Handle |