PROCOTYL® P ENZTEC THREADED ADAPTER PPENZTHA
GUDID 09421028118873
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable| Primary Device ID | 09421028118873 |
| NIH Device Record Key | c3b8fb49-1381-4df1-aebf-53076f3df050 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCOTYL® P ENZTEC THREADED ADAPTER |
| Version Model Number | PPENZTHA |
| Catalog Number | PPENZTHA |
| 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 | 09421028118873 [Primary] |
FDA Product Code
| HWA | Impactor |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
Moist Heat or Steam Sterilization
[09421028118873]
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
| 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 |
| 09421028119023 - Enztec Straight Cup Impactor | 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119009 - Double Offset Broach Handle M2 Connection - Right | 2024-02-16 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119016 - Double Offset Broach Handle M2 Connection - Left | 2024-02-16 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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