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K -Wire, Cr Co, Blunt Sharp Tip, L=289, Ø1.65mm Short screwdriver+ DKWA
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- K -Wire, Cr Co, Blunt Sharp Tip, L=289, Ø1.65mm Short screwdriver+ DKWA FDA UDI
- Generic Name
- Spinal guidewire FDA UDI
- Model / Reference
- 88356 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115935202 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Spinal guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal guidewire
K -Wire, Cr Co, Blunt Sharp Tip, L=289, Ø1.65mm Short screwdriver+ DKWA by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Spinal guidewire.
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- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
Cleared under the same submission
K150380 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
- Head Releaser — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA — PREMIA SPINE LTD
- MIS Cannulated Pedicle Probe — PREMIA SPINE LTD
- MIS Compressor — PREMIA SPINE LTD
K170061 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
- Head Releaser — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA — PREMIA SPINE LTD
- K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill — PREMIA SPINE LTD
- K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA — PREMIA SPINE LTD
K231844 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
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
- Premia Spine Ltd
Sources (1)
- FDA UDI 3657b897-ad82-4f7e-b3b0-ec29570d56b0 33 fields · synced May 31, 2026