| Primary Device ID | 09421038410028 |
| NIH Device Record Key | 27602a35-4001-4638-bee1-45985a9eab03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patella Drill Guide – Corentec 40 |
| Version Model Number | 4240-4240 |
| Catalog Number | 4240-4240 |
| 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 | 09421038410028 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
[09421038410028]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-07 |
| Device Publish Date | 2025-07-30 |
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| 09421038410530 - Enztec Trinket M8x1.00-03 | 2026-01-13 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421038411612 - Offset Acetabular Shell Impactor Hex Driver - Enztec | 2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421038411629 - Offset Acetabular Shell Impactor Trinket - Enztec | 2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |