Hyper-C

FDA UDI

Class I (US FDA UDI)

by Degen Medical

Identity

Trade Name: Hyper-C FDA UDI
Generic Name: Bone tack inserter, basic FDA UDI
Device Name: Fixation Pin Driver Assy FDA UDI
Model / Reference: 02-12P FDA UDI
Description: Fixation Pin Driver Assy FDA UDI

Identifiers

Catalog Number: 02-12P FDA UDI
Primary DI / UDI-DI: 00842048152156 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone tack inserter, basic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone tack inserter, basic

Hyper-C by Degen Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone tack inserter, basic.

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Offset Tip — MC BIO SRL · Class I
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BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
Standard tip — MC BIO SRL · Class I
Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
HALLMARK — Orthofix US LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Degen Medical

Sources (1)

FDA UDI 4684caec-6985-4eae-b0c0-f9af83c528ce 35 fields · synced May 30, 2026