Primary Device ID | 09421028118569 |
NIH Device Record Key | bb4fd663-01dd-41ff-a701-1cec6af14c97 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Enztec Alignment Guide - Lateral 45° - 20° |
Version Model Number | 4252-2220 |
Catalog Number | 4252-2220 |
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 | 09421028118569 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
[09421028118569]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-23 |
Device Publish Date | 2024-08-15 |
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 |