PROCOTYL® P ENZTEC LATERAL ALIGNMENT GUIDE PPENZLAG
GUDID 09421028118934
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 09421028118934 |
| NIH Device Record Key | 2f9702bb-5a8b-4273-98ac-ed10cabd8b35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCOTYL® P ENZTEC LATERAL ALIGNMENT GUIDE |
| Version Model Number | PPENZLAG |
| Catalog Number | PPENZLAG |
| 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 | 09421028118934 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
[09421028118934]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-23 |
| Device Publish Date | 2024-08-15 |
Devices Manufactured by ENZTEC LIMITED
| 09421038411261 - Enovis Straight Reamer Driver - Locking - Crossbar - Zimmer | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411278 - Enovis Straight Reamer Driver - Locking - Crossbar - Hudson | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411285 - Enovis Straight Reamer Driver - Locking - Crossbar - Large AO | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411704 - Offset Reamer Coupling – Zimmer Adapter | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411711 - Offset Reamer Drive Train | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411728 - Offset Reamer Cover | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411735 - Offset Reamer Handle | 2025-12-23 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure |
| 09421038411803 - UNIVERSAL ACETABULAR OFFSET REAMER DRIVER | 2025-12-23 A surgical instrument connected to an active device 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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