← Back to catalogue
TwistCut™ EndoSorb bioabsorbable Snap-Off Screw
FDA UDIClass II (US FDA UDI)
by Merete GmbH
Identity
- Trade Name
- TwistCut™ EndoSorb bioabsorbable Snap-Off Screw FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- PLGA sterile FDA UDI
- Model / Reference
- 2.5 28 FDA UDI
- Description
- PLGA sterile FDA UDI
Identifiers
- Catalog Number
- FP25028 FDA UDI
- Primary DI / UDI-DI
- 04048266010322 FDA UDI
- 510(k) Number
- K102777 FDA UDI
- FDA Product Code
- HWC FDA UDIJDW FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Dimensions & Sizes
- Size
- Length — 28 Millimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDI
TwistCut™ EndoSorb bioabsorbable Snap-Off Screw by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merete GmbH
Sources (1)
- FDA UDI 81c68446-912d-4900-9960-72bedd3a13ef 38 fields · synced Jun 8, 2026