| Primary Device ID | 07899258629322 |
| NIH Device Record Key | ec7afd97-f250-40d5-88c3-b8ca5b4c2b1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMReis Ankle Plating System |
| Version Model Number | VERSA TORXDRIVE SCREW LOW PROFILE Ø3.5/2.7MMX36MM |
| Catalog Number | 223-3527-36-C |
| Company DUNS | 900865213 |
| Company Name | GM DOS REIS INDUSTRIA E COMERCIO LTDA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 07899258629322 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
[07899258629322]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-12 |
| Device Publish Date | 2024-12-04 |
| 07899258656076 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 10 HOLES 2.7/3.5MM |
| 07899258656069 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 12 HOLES 2.7/3.5MM |
| 07899258656052 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 18 HOLES 2.7/3.5MM |
| 07899258656045 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 18 HOLES 2.7/3.5MM |
| 07899258656038 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 16 HOLES 2.7/3.5MM |
| 07899258656021 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 16 HOLES 2.7/3.5MM |
| 07899258656014 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 14 HOLES 2.7/3.5MM |
| 07899258655994 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 12 HOLES 2.7/3.5MM |
| 07899258655987 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 12 HOLES 2.7/3.5MM |
| 07899258655970 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 10 HOLES 2.7/3.5MM |
| 07899258655925 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 16 HOLES 2.7/3.5MM |
| 07899258655918 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 16 HOLES 2.7/3.5MM |
| 07899258655901 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 14 HOLES 2.7/3.5MM |
| 07899258655895 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 12 HOLES 2.7/3.5MM |
| 07899258655857 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 08 HOLES 2.7/3.5MM |
| 07899258655840 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 08 HOLES 2.7/3.5MM |
| 07899258655833 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 06 HOLES 2.7/3.5MM |
| 07899258655826 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 06 HOLES 2.7/3.5MM |
| 07899258655819 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 04 HOLES 2.7/3.5MM |
| 07899258655802 | ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 04 HOLES 2.7/3.5MM |
| 07899258655796 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM |
| 07899258655789 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 08 HOLES 2.7/3.5MM |
| 07899258655772 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 04 HOLES 2.7/3.5MM |
| 07899258655765 | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 13 HOLES - 2.7/3.5 |
| 07899258655758 | VERSALOCK PLATE POSTERIOR MALLEOLUS T 04 HOLES 2.7MM |
| 07899258655574 | VERSALOCK PLATE POSTERIOR MALLEOLUS T 03 HOLES 2.7MM |
| 07899258655567 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 10 HOLES 2.7/3.5MM |
| 07899258655550 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 10 HOLES 2.7/3.5MM |
| 07899258655543 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 08 HOLES 2.7/3.5MM |
| 07899258655536 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 06 HOLES 2.7/3.5MM |
| 07899258655529 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 06 HOLES 2.7/3.5MM |
| 07899258655512 | ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 04 HOLES 2.7/3.5MM |
| 07899258655505 | VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 07 HOLES 2.7/3.5MM |
| 07899258655499 | VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 05 HOLES 2.7/3.5MM |
| 07899258655482 | VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 03 HOLES 2.7/3.5MM |
| 07899258655475 | VERSALOCK VERSATILE PLATE 10 HOLES 3.5MM |
| 07899258655468 | VERSALOCK VERSATILE PLATE 08 HOLES 3.5MM |
| 07899258655451 | VERSALOCK VERSATILE PLATE 07 HOLES 3.5MM |
| 07899258655444 | ANATOMICAL FIBULA VERSALOCK PLATE LEFT 15 HOLES - 2.7/3.5 |
| 07899258655437 | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 15 HOLES - 2.7/3.5 |
| 07899258655420 | ANATOMICAL FIBULA VERSALOCK PLATE LEFT 13 HOLES - 2.7/3.5 |
| 07899258655413 | ANATOMICAL FIBULA VERSALOCK PLATE LEFT 11 HOLES - 2.7/3.5 |
| 07899258655406 | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 11 HOLES - 2.7/3.5 |
| 07899258655390 | ANATOMICAL FIBULA VERSALOCK PLATE LEFT 09 HOLES - 2.7/3.5 |
| 07899258655383 | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 09 HOLES - 2.7/3.5 |
| 07899258655345 | ANATOMICAL FIBULA VERSALOCK PLATE LEFT 05 HOLES - 2.7/3.5 |
| 07899258655284 | ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 07 HOLES - 2.7/3.5 |
| 07899258655260 | VERSALOCK PLATE DISTAL FIBULA HOOK 07 HOLES 2.7/3.5MM |
| 07899258655253 | VERSALOCK PLATE DISTAL FIBULA HOOK 05 HOLES 2.7/3.5MM |
| 07899258655246 | VERSALOCK PLATE DISTAL FIBULA HOOK 03 HOLES 2.7/3.5MM |