| Primary Device ID | 09421028119467 |
| NIH Device Record Key | e221415e-a7ea-4cc2-abb8-e60fe84a2169 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enztec Femoral Impactor with Slap Hammer – Corentec |
| Version Model Number | 4240-3102 |
| Catalog Number | 4240-3102 |
| 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 | 09421028119467 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
[09421028119467]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-20 |
| Device Publish Date | 2024-06-12 |
| 09421028119467 - Enztec Femoral Impactor with Slap Hammer – Corentec | 2024-06-20A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119467 - Enztec Femoral Impactor with Slap Hammer – Corentec | 2024-06-20 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119474 - Corentec Femoral Impactor Head | 2024-06-20 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119238 - Enztec Trinket M8X1.00-01 | 2024-05-24 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028116756 - Exactech Straight DA Broach Handle | 2024-04-22 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119245 - Enztec Trinket M10X1.00-01 | 2024-03-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119108 - Bone Hook | 2024-03-19 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118910 - PROCOTYL® P ENZTEC LINER IMPACTOR ADAPTER | 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118941 - PROCOTYL® P ENZTEC STRAIGHT HANDLE | 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |