Identity
- Trade Name
- K-Wires trocar tip round end FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- CrNiMo non-sterile QTY 10 FDA UDI
- Model / Reference
- 1.00 80 FDA UDI
- Description
- CrNiMo non-sterile QTY 10 FDA UDI
Identifiers
- Catalog Number
- CK10008 FDA UDI
- Primary DI / UDI-DI
- 04048266059772 FDA UDI
- 510(k) Number
- K120787 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDIOuter Diameter — 1 Millimeter FDA UDI
Category: Orthopaedic bone wire
K-Wires trocar tip round end by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120787 also covers:
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
- K-Wires trocar tip round end — Merete GmbH
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 a1a9fe77-bb2a-422d-9abe-2da3529dbcea 37 fields · synced May 30, 2026