| Primary Device ID | 07630055303813 |
| NIH Device Record Key | d5f30a02-76cf-4b15-a64e-cc665dc04534 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Offset reamer handle - Hudson - Tri coupling (NC) |
| Version Model Number | 50244532 |
| Catalog Number | 00-502-445-32 |
| 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 | 07630055303813 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
[07630055303813]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
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| 07630055305275 - ACE Acetabular Reamer 38mm | 2025-05-08 Acetabular Reamer |
| 07630055305282 - ACE Acetabular Reamer 39mm | 2025-05-08 Acetabular Reamer |
| 07630055305299 - ACE Acetabular Reamer 40mm | 2025-05-08 Acetabular Reamer |
| 07630055305305 - ACE Acetabular Reamer 41mm | 2025-05-08 Acetabular Reamer |
| 07630055305312 - ACE Acetabular Reamer 42mm | 2025-05-08 Acetabular Reamer |
| 07630055305329 - ACE Acetabular Reamer 43mm | 2025-05-08 Acetabular Reamer |