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Golden Isles Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Intelivation, LLC

Identity

Trade Name
Golden Isles Pedicle Screw System FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
Inline Torque Handle, 40 in/lb FDA UDI
Model / Reference
C11-5000-018 FDA UDI
Description
Inline Torque Handle, 40 in/lb FDA UDI

Identifiers

Primary DI / UDI-DI
G079C1150000180 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Surgical instrument handle, 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, torque-limiting

Golden Isles Pedicle Screw System by Intelivation, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intelivation, LLC

Sources (1)

  • FDA UDI 58a9bc27-3690-4ef7-bcd3-5c73e01237f3 34 fields · synced Jun 8, 2026