PROCOTYL® P ENZTEC LINER IMPACTOR ADAPTER PPENZLMA
GUDID 09421028118910
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
Orthopaedic implant impactor, reusable| Primary Device ID | 09421028118910 |
| NIH Device Record Key | bd8b9e36-87ae-440a-b125-3c5b7c3de8c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCOTYL® P ENZTEC LINER IMPACTOR ADAPTER |
| Version Model Number | PPENZLMA |
| Catalog Number | PPENZLMA |
| 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 | 09421028118910 [Primary] |
FDA Product Code
| HWA | Impactor |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
[09421028118910]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
Devices Manufactured by ENZTEC LIMITED
| 09421028119320 - Intramedullary Alignment Jig | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119337 - Intramedullary Rod Lock Knob | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119344 - Spiked EM Alignment Jig | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119351 - Spiked EM Slope Guide | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119368 - Spiked EM/IM Alignment Rod | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119375 - Lock Knob | 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 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 |
Trademark Results [PROCOTYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCOTYL 78558986 3163841 Live/Registered |
Wright Medical Technology, Inc. 2005-02-02 |
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