| Primary Device ID | 09421028119566 |
| NIH Device Record Key | 11b4aff1-bff6-49fb-8068-9edc0699ea2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enztec XR Trinket 3/8-24 UNF-01 |
| Version Model Number | 4252-2443 |
| Catalog Number | 4252-2443 |
| Company DUNS | 592616445 |
| Company Name | ENZTEC LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 09421028119566 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028119566]
Moist Heat or Steam Sterilization
[09421028119566]
Moist Heat or Steam Sterilization
[09421028119566]
Moist Heat or Steam Sterilization
[09421028119566]
Moist Heat or Steam Sterilization
[09421028119566]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
| 09421028112963 - Kinematic Alignment Caliper | 2024-10-21 Intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces |
| 09421038410080 - Enztec Trinket 3/8-16 UNC-03 | 2024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421038410295 - Enztec Trinket M8x1.25-02 | 2024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119252 - Enztec Trinket 3/8-24 UNF-03 | 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119900 - Enztec Trinket 5/16-24 UNF-01 | 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119924 - Enztec Trinket M8x1.25-01 | 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028115056 - Enztec Cup Impactor Alignment Guide - Supine | 2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028115063 - Enztec Cup Impactor Alignment Guide - Lateral | 2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |