Identity
- Trade Name
- DKWA T- Handle, Coupling Connection FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Model / Reference
- 88168 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115935172 FDA UDI
- PMA Number
- P220002 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDIQWK FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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
No
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: Surgical instrument handle, non-torque-limiting
DKWA T- Handle, Coupling Connection by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
P220002 also covers:
- Alignment Gauge handle Long — PREMIA SPINE LTD
- Alignment Gauge handle Medium — PREMIA SPINE LTD
- Ball Probe — PREMIA SPINE LTD
- Cannulated Pedicle Awl — PREMIA SPINE LTD
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 5.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø5.5 XL — PREMIA SPINE LTD
- Cannulated Tap Ø6.5 XL — PREMIA SPINE LTD
- Counter Torque — PREMIA SPINE LTD
- Depth Gauge and Feeler — 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 0b5b6a11-eb34-4842-a491-43eaf079ff24 33 fields · synced May 30, 2026