INTREPED Extraction Kit

FDA UDI

Class I (US FDA UDI)

by Auxano Medical LLC

Identity

Trade Name: INTREPED Extraction Kit FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: The INTREPED Extraction Kit includes instruments and tray for implant explant. FDA UDI
Model / Reference: 01-00006 FDA UDI
Description: The INTREPED Extraction Kit includes instruments and tray for implant explant. FDA UDI

Identifiers

Catalog Number: 01-00006 FDA UDI
Primary DI / UDI-DI: 00850055649705 FDA UDI
FDA Product Code: HWK FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic bone screw (non-sliding)

INTREPED Extraction Kit by Auxano Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

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STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

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: Auxano Medical LLC

Sources (1)

FDA UDI 6dde06a0-23b8-46b8-9102-39b8cc410339 35 fields · synced Jun 1, 2026