Integra® Miltex®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® Miltex® FDA UDI
Generic Name: Skin marking guide, reusable FDA UDI
Device Name: Integra® Miltex® D'Assumpcao Rhytidoplasty Marker, 6-1/4", With Ratchet FDA UDI
Model / Reference: PM-391 FDA UDI
Description: Integra® Miltex® D'Assumpcao Rhytidoplasty Marker, 6-1/4", With Ratchet FDA UDI

Identifiers

Catalog Number: PM-391 FDA UDI
Primary DI / UDI-DI: 10381780503392 FDA UDI
FDA Product Code: GDJ FDA UDI
GMDN Term: Skin marking guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Skin marking guide, reusable

Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI 6ae3f75a-167b-434c-b824-b25666c0fafa 35 fields · synced Jun 9, 2026