Identity
- Trade Name
- LnK Spinal Fixation System FDA UDI
- Generic Name
- Post-PCR cleanup kit IVD FDA UDI
- Device Name
- L&K Biomed Reductionn Mono Axial Screw 5.0x45mm 1EA FDA UDI
- Model / Reference
- 1131-5045 FDA UDI
- Description
- L&K Biomed Reductionn Mono Axial Screw 5.0x45mm 1EA FDA UDI
Identifiers
- Catalog Number
- 1131-5045 FDA UDI
- Primary DI / UDI-DI
- 08806189808039 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDIKWQ FDA UDIKWP FDA UDI
- GMDN Term
- Post-PCR cleanup kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 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
No
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
Category: Post-PCR cleanup kit IVD
LnK Spinal Fixation System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- L&K Biomed Co. , Ltd.
Sources (1)
- FDA UDI 93875d76-209f-4b2f-8aff-4b7dec8de23b 34 fields · synced May 30, 2026