| Primary Device ID | 09120034309311 | 
| NIH Device Record Key | f4ad5f25-3905-4ef4-91f9-2cefba048ee2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Proximal Lateral Tibia Plate | 
| Version Model Number | 21322-4 | 
| Catalog Number | 21322-4 | 
| 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 | 09120034309311 [Primary] | 
| HRS | Plate, Fixation, Bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
Moist Heat or Steam Sterilization
[09120034309311]
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 | 2016-09-08 | 
| 09120034309311 | Proximal Lateral Tibia Plate, 4-Hole, Left | 
| 09120034309304 | Proximal Lateral Tibia Plate, 4-Hole, Right | 
| 09120034307140 | Proximal Lateral Tibia Plate, 17-Hole, Left | 
| 09120034307133 | Proximal Lateral Tibia Plate, 12-Hole, Left | 
| 09120034307126 | Proximal Lateral Tibia Plate, 7-Hole, Left | 
| 09120034307119 | Proximal Lateral Tibia Plate, 17-Hole, Right | 
| 09120034307102 | Proximal Lateral Tibia Plate, 12-Hole, Right | 
| 09120034307096 | Proximal Lateral Tibia Plate, 7-Hole, Right |