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Humeral Locking Plate, Titanium Alloy
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 021800014Ref 021901004Ref 025690007Ref 021800013Ref 025850008Ref 021902007Ref 021800006Ref 021891009Ref 021902006Ref 021800010Ref 021891003Ref 025870008Ref 021800007Ref 021800015Ref 021891006Ref 025690010Ref 025850012Ref 025690008Ref 025850010Ref 025870006Ref 021901006Ref 025850006Ref 025870012Ref 021800005Ref 021902008Ref 021382003Ref 021891010
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
- 021800014 EUDAMED021901004 EUDAMED025690007 EUDAMED021800013 EUDAMED025850008 EUDAMED021902007 EUDAMED021800006 EUDAMED021891009 EUDAMED021902006 EUDAMED021800010 EUDAMED021891003 EUDAMED025870008 EUDAMED021800007 EUDAMED021800015 EUDAMED021891006 EUDAMED025690010 EUDAMED025850012 EUDAMED025690008 EUDAMED025850010 EUDAMED025870006 EUDAMED021901006 EUDAMED025850006 EUDAMED025870012 EUDAMED021800005 EUDAMED021902008 EUDAMED021382003 EUDAMEDFDA UDI021891010 EUDAMED
Identifiers
- Catalog Number
- 021382003 FDA UDI
- Primary DI / UDI-DI
- 06942782483791 EUDAMED06942782493493 EUDAMED06902139426482 EUDAMED06942782483784 EUDAMED06902139000088 EUDAMED06942782493578 EUDAMED06942782483715 EUDAMED06942782487041 EUDAMED06942782493561 EUDAMED06942782483753 EUDAMED06942782493592 EUDAMED06902139000163 EUDAMED06942782483722 EUDAMED06942782483807 EUDAMED06942782493622 EUDAMED06902139426512 EUDAMED06902139000125 EUDAMED06902139426499 EUDAMED06902139000101 EUDAMED06902139000156 EUDAMED06942782493509 EUDAMED06902139000064 EUDAMED06902139000187 EUDAMED06942782483708 EUDAMED06942782493585 EUDAMED06942782481490 EUDAMEDFDA UDI06902139467768 EUDAMED
- Basic UDI-DI
- 6902139CS03002AR EUDAMED
- Direct Marketing DI
- 06942782483791 EUDAMED06942782493493 EUDAMED06902139426482 EUDAMED06942782483784 EUDAMED06902139000088 EUDAMED06942782493578 EUDAMED06942782483715 EUDAMED06942782487041 EUDAMED06942782493561 EUDAMED06942782483753 EUDAMED06942782493592 EUDAMED06902139000163 EUDAMED06942782483722 EUDAMED06942782483807 EUDAMED06942782493622 EUDAMED06902139426512 EUDAMED06902139000125 EUDAMED06902139426499 EUDAMED06902139000101 EUDAMED06902139000156 EUDAMED06942782493509 EUDAMED06902139000064 EUDAMED06902139000187 EUDAMED06942782483708 EUDAMED06942782493585 EUDAMED06942782481490 EUDAMED06902139467768 EUDAMED
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS 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
- 888.3040 FDA UDI888.3030 FDA UDI
- Market of Registration
- Slovenia EUDAMEDRomania EUDAMEDLatvia EUDAMEDCroatia EUDAMEDPoland EUDAMEDBulgaria 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
- Width — 11.2 Millimeter FDA UDILength — 58.0 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 (28)
- EUDAMED 6589e1cc-173e-49a2-870f-1bcdd588b293 61 fields · synced Aug 3, 2026
- EUDAMED 11c84c61-c25f-4e2b-99cc-abc1d64e3cd2 61 fields · synced May 16, 2026
- EUDAMED 79feb072-0328-42ab-a873-8c5fe6e57bee 61 fields · synced May 16, 2026
- EUDAMED f69b90ff-953c-4289-b046-e9721dfb744a 61 fields · synced May 16, 2026
- EUDAMED 1c0c5581-3414-4dbe-8c93-d706cde3113c 61 fields · synced May 16, 2026
- EUDAMED d8bf3d55-51db-4c66-9366-32075915b909 61 fields · synced May 16, 2026
- EUDAMED 294fcee5-fa66-4118-8870-6c5aa549370b 61 fields · synced May 17, 2026
- EUDAMED ca657b07-3266-4cc5-885e-463132a9eb58 61 fields · synced May 17, 2026
- EUDAMED cb5a8d8b-114f-449b-8cbf-1f430d51dfba 61 fields · synced May 17, 2026
- EUDAMED c5589c68-9c74-4d90-9bbd-8243e0bcad4a 61 fields · synced May 17, 2026
- EUDAMED f26bfc8a-6b3c-4d73-8718-c8834fe5e7fe 61 fields · synced May 17, 2026
- EUDAMED 046e5445-25f4-4e7c-bc7a-11b5cf8ea78a 61 fields · synced May 17, 2026
- EUDAMED 6316e335-7b71-4005-9211-69695da4f435 61 fields · synced May 17, 2026
- EUDAMED f016d461-92a6-467a-adcd-773d9b6b72ac 61 fields · synced May 18, 2026
- EUDAMED fd52b850-56f3-42a2-8614-1f509aac4d06 61 fields · synced May 18, 2026
- EUDAMED 8eac0f93-fce2-4ff5-89c5-6795277fdd81 61 fields · synced May 18, 2026
- EUDAMED e74aa2f4-8a36-4534-8eb6-b314cd13e05c 61 fields · synced May 18, 2026
- EUDAMED 02402222-5e49-4cd4-9623-9a1b65a8ca7c 61 fields · synced May 18, 2026
- EUDAMED 41b23c46-67a2-4fb1-92c1-0c6c7c4c61de 61 fields · synced May 18, 2026
- EUDAMED cab2af45-e817-439b-92da-6dadf425ae40 61 fields · synced May 18, 2026
- EUDAMED c7af2e22-c687-4ca8-8aaa-0b2822de7ef0 61 fields · synced May 18, 2026
- EUDAMED 1337121c-17aa-4679-8392-fe273cd06a0e 61 fields · synced May 18, 2026
- EUDAMED b714e868-4755-41bf-ba1c-366684fabdbc 61 fields · synced May 18, 2026
- EUDAMED 96884bd2-22ec-44cf-b333-7dd049a177fc 61 fields · synced May 19, 2026
- EUDAMED d4582102-386a-418d-bc74-c6eb909ff59f 61 fields · synced May 19, 2026
- EUDAMED 8be8823c-bd82-4c2f-921e-25eb65018282 61 fields · synced May 19, 2026
- EUDAMED 3a04106a-92d6-4c5c-b82c-3f619cd7ae89 61 fields · synced May 19, 2026
- FDA UDI e43af412-baa5-4634-9954-10767a2c657d 36 fields · synced May 30, 2026