| Primary Device ID | 09421038411261 |
| NIH Device Record Key | f3b53cff-b904-4ccc-a3fe-fa1cd9f7000c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enovis Straight Reamer Driver - Locking - Crossbar - Zimmer |
| Version Model Number | 90ST.EN.ZH1 |
| Catalog Number | 90ST.EN.ZH1 |
| 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 | 09421038411261 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421038411261]
Moist Heat or Steam Sterilization
[09421038411261]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 09421038411261 - Enovis Straight Reamer Driver - Locking - Crossbar - Zimmer | 2025-12-23A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411261 - Enovis Straight Reamer Driver - Locking - Crossbar - Zimmer | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411278 - Enovis Straight Reamer Driver - Locking - Crossbar - Hudson | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411285 - Enovis Straight Reamer Driver - Locking - Crossbar - Large AO | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411704 - Offset Reamer Coupling – Zimmer Adapter | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411711 - Offset Reamer Drive Train | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411728 - Offset Reamer Cover | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411735 - Offset Reamer Handle | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411803 - UNIVERSAL ACETABULAR OFFSET REAMER DRIVER | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |