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4.0mm Cancellous Screw, half threaded, 14mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 040020014
Identity
- Trade Name
- 4.0mm Cancellous Screw, half threaded, 14mm EUDAMED4.0mm Cancellous Screw, Half Threaded FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Non-locking Screw(Cancellous) EUDAMED
- Model / Reference
- 040020014 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 040020014 FDA UDI
- Primary DI / UDI-DI
- 06942782469009 EUDAMEDFDA UDI
- Basic UDI-DI
- 6902139CS01002AB EUDAMED
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Market of Registration
- Spain 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
No
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 — 14.0 Millimeter FDA UDI
4.0mm Cancellous Screw, half threaded, 14mm 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 | 6902139CS01002AB | 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 8c57261e-625e-4e64-a1e5-0b629d53fdbc 61 fields · synced Aug 4, 2026
- FDA UDI 62481200-7c43-4bb1-8ac4-b0c1a3042870 36 fields · synced May 30, 2026