| Primary Device ID | 09120047307311 | 
| NIH Device Record Key | a2884ba4-ef84-40e6-99a4-3ffbf1e759dc | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Proximal Medial Tibia Plate | 
| Version Model Number | 21325-4 | 
| Catalog Number | 21325-4 | 
| Company DUNS | 303456917 | 
| Company Name | I.T.S. GmbH | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | true | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 09120047307311 [Primary] | 
| HRS | Plate, Fixation, Bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
[09120047307311]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2024-08-08 | 
| Device Publish Date | 2016-09-12 | 
| 09120047307328 | Proximal Medial Tibia Plate, 7-Hole | 
| 09120047307311 | Proximal Medial Tibia Plate, 4-Hole |