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Humeral Locking Plate, Titanium Alloy
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 021381009
Identity
- Trade Name
- Distal Medial Humeral Locking Plate, Combi-holes FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Humeral Locking Plate, Titanium Alloy EUDAMED
- Model / Reference
- 021381009 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 021381009 FDA UDI
- Primary DI / UDI-DI
- 06942782481483 EUDAMEDFDA UDI
- Basic UDI-DI
- 6902139CS03002AR EUDAMED
- Direct Marketing DI
- 06942782481483 EUDAMED
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 136.0 Millimeter FDA UDIWidth — 11.2 Millimeter FDA UDI
Humeral Locking Plate, Titanium Alloy by Double Medical Technology Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6902139CS03002AR | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 95c0fbe6-08ed-4bf2-b1c8-e1a47ad256e8 61 fields · synced Jun 19, 2026
- FDA UDI b88abcae-393f-46ad-b1dd-68600063662b 36 fields · synced May 30, 2026