PROCOTYL® P ENZTEC STRAIGHT HEX DRIVER PPENZHEX
GUDID 09421028118965
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
Orthopaedic implant impactor, reusable| Primary Device ID | 09421028118965 |
| NIH Device Record Key | 92aa520d-b8be-4be1-9725-731ceb1d41f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCOTYL® P ENZTEC STRAIGHT HEX DRIVER |
| Version Model Number | PPENZHEX |
| Catalog Number | PPENZHEX |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421028118965 [Primary] |
FDA Product Code
| HWA | Impactor |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
[09421028118965]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-16 |
| Device Publish Date | 2023-11-08 |
Devices Manufactured by ENZTEC LIMITED
| 09421038410288 - Enztec Patella Shim - 4mm | 2024-12-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118651 - Adjustable Cutting Block – 1.35mm | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118668 - 3.5mm Ball Hex Driver – 340mm | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119030 - Adjustable Cutting Block – 1.27mm | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119085 - MODULAR BROACH HANDLE, GRIP | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE | 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
Trademark Results [PROCOTYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCOTYL 78558986 3163841 Live/Registered |
Wright Medical Technology, Inc. 2005-02-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.