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Radius and Ulnar Locking Plate, pure titanium
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 020111011Ref 020111012Ref 020112011Ref 020112012Ref 020111004Ref 020112005Ref 020112003Ref 020112006Ref 020102005Ref 020112004Ref 020112008Ref 020632007Ref 020101003Ref 020111005Ref 020111009Ref 020641003
Identity
- Trade Name
- Distal Radius Locking Plate I, Large, Combi-holes FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Radius and Ulnar Locking Plate, pure titanium EUDAMED
- Model / Reference
- 020111011 EUDAMED020111012 EUDAMED020112011 EUDAMED020112012 EUDAMED020111004 EUDAMED020112005 EUDAMED020112003 EUDAMED020112006 EUDAMED020102005 EUDAMED020112004 EUDAMED020112008 EUDAMED020632007 EUDAMED020101003 EUDAMED020111005 EUDAMED020111009 EUDAMED020641003 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 020641003 FDA UDI
- Primary DI / UDI-DI
- 06902139536341 EUDAMED06902139536358 EUDAMED06902139536389 EUDAMED06902139536396 EUDAMED06942782407155 EUDAMED06942782407216 EUDAMED06942782433543 EUDAMED06942782407223 EUDAMED06942782404642 EUDAMED06942782407209 EUDAMED06942782407247 EUDAMED06902139536433 EUDAMED06942782404581 EUDAMED06942782407162 EUDAMED06902139536327 EUDAMED06942782451837 EUDAMEDFDA UDI
- Basic UDI-DI
- 6902139CS03005AX 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
- Latvia EUDAMEDCroatia EUDAMEDRomania EUDAMEDBulgaria EUDAMEDCyprus 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 — 55.0 Millimeter FDA UDIWidth — 8.0 Millimeter FDA UDI
Radius and Ulnar Locking Plate, pure titanium by Double Medical Technology Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 6902139CS03005AX | 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 (17)
- EUDAMED 108dab5f-f9b0-4a74-a37f-f44443805f67 61 fields · synced Aug 3, 2026
- EUDAMED 6371437a-4226-42da-9516-04fb8fbe1007 61 fields · synced May 17, 2026
- EUDAMED 8b03bafe-e4ca-4828-9db9-ef13597bb491 61 fields · synced May 17, 2026
- EUDAMED c7f65b28-6b6e-4112-b11f-b20f57d4c519 61 fields · synced May 17, 2026
- EUDAMED 02565da2-8be0-4d3c-acf8-ee26f71bce73 61 fields · synced May 17, 2026
- EUDAMED 7dafc973-c077-4af4-bc99-c16151ff9328 61 fields · synced May 17, 2026
- EUDAMED c488e00c-f383-4f9d-b9f8-37859d3fc9d7 61 fields · synced May 17, 2026
- EUDAMED e2f957a8-e8ff-4010-b927-4fdd9a9437f2 61 fields · synced May 17, 2026
- EUDAMED d29ae594-4c2f-408a-81d6-6e2ab12421f8 61 fields · synced May 18, 2026
- EUDAMED e0c19bad-180e-4a1a-b617-a503ed9afc4c 61 fields · synced May 18, 2026
- EUDAMED 9ec2da89-fb2d-4fcd-870b-ed60231c6d06 61 fields · synced May 18, 2026
- EUDAMED f306a439-7172-4ded-977d-945b8eef761f 61 fields · synced May 18, 2026
- EUDAMED 52cb3df0-727b-40e8-bc92-19b60c952d6d 61 fields · synced May 18, 2026
- EUDAMED 67b14c08-a2e3-404c-afba-d9a370e18645 61 fields · synced May 18, 2026
- EUDAMED 4c3830ab-6e6c-42aa-8409-6f6176471367 61 fields · synced May 18, 2026
- EUDAMED 87a910cf-95db-4349-9883-c9de7920920c 61 fields · synced May 19, 2026
- FDA UDI 0778bdb2-79c0-420f-8cd5-bd69b5b33ce7 36 fields · synced May 29, 2026