InstaFix Shape Memory Fixation System

FDA UDI

Class II (US FDA UDI)

by OT medical GmbH

Identity

Trade Name: InstaFix Shape Memory Fixation System FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Model / Reference: 400-3724 FDA UDI

Identifiers

Catalog Number: 400-3724 FDA UDI
Primary DI / UDI-DI: B04140037240 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 25 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI

Category: Orthopaedic bone staple, non-adjustable

InstaFix Shape Memory Fixation System by OT medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: OT medical GmbH

Sources (1)

FDA UDI 84856b79-77ed-480f-a0cd-269e73551ca0 35 fields · synced May 30, 2026