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Mini and Micro Fragments Reconstruction System - GMReis
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Mini and Micro Fragments Reconstruction System - GMReis FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- LOCKING VERSALOCK SCREW TORXDRIVE Ti T7 Ø2,4x16mm LOW PROFILE FDA UDI
- Model / Reference
- Locking Screw FDA UDI
- Description
- LOCKING VERSALOCK SCREW TORXDRIVE Ti T7 Ø2,4x16mm LOW PROFILE FDA UDI
Identifiers
- Catalog Number
- 223-24-16-BPB FDA UDI
- Primary DI / UDI-DI
- 07899258613420 FDA UDI
- 510(k) Number
- K242596 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Mini and Micro Fragments Reconstruction System - GMReis by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K242596 also covers:
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI 9e54a9bc-1fa3-4015-966f-91f15fbe603d 35 fields · synced May 31, 2026