| Primary Device ID | 09421038412312 |
| NIH Device Record Key | 31247a0c-eaaf-4f40-b358-fd9d6303e4ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cup reamer handle, offset, AO, open |
| Version Model Number | 9209-1312 |
| Catalog Number | 9209-1312 |
| Company DUNS | 592616445 |
| Company Name | ENZTEC LIMITED |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421038412312 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
[09421038412312]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| 09421038412145 - Cup reamer handle, offset, Z/H, locking | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412152 - Offset coupling, Z/H | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412169 - Offset drive train, locking | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412176 - Short Offset Cover – United | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412183 - Handle – United | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412299 - Cup reamer handle, offset, AO, locking | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412305 - Offset coupling, AO | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412312 - Cup reamer handle, offset, AO, open | 2026-03-17A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038412312 - Cup reamer handle, offset, AO, open | 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |