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Dark Star Deformity

FDA UDI

Class II (US FDA UDI)

by Republic Spine, LLC

Identity

Trade Name
Dark Star Deformity FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
Counter Torque Wrench FDA UDI
Model / Reference
100273 FDA UDI
Description
Counter Torque Wrench FDA UDI

Identifiers

Catalog Number
DS0007 FDA UDI
Primary DI / UDI-DI
B0751002730 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
NKB FDA UDI
KWP FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Dark Star Deformity by Republic Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Republic Spine, LLC

Sources (1)

  • FDA UDI 490d02cb-2414-466a-8810-9eac6c87c8a2 35 fields · synced May 30, 2026