Integra® Miltex®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® Miltex® FDA UDI
Generic Name: Nasal file/rasp FDA UDI
Device Name: Integra® Miltex® Maltz Nasal Rasp 6-1/2", Straight, Reverse Cutting, Tungsten Carbide FDA UDI
Model / Reference: PM-1448TC FDA UDI
Description: Integra® Miltex® Maltz Nasal Rasp 6-1/2", Straight, Reverse Cutting, Tungsten Carbide FDA UDI

Identifiers

Catalog Number: PM-1448TC FDA UDI
Primary DI / UDI-DI: 10381780451846 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Nasal file/rasp 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: Nasal file/rasp

Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal file/rasp.

Ambler Surgical — Ambler Surgical, LLC · Class I
AESCULAP — AESCULAP, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Parkes nasal rasp — Spiggle & Theis Medizintechnik GmbH · Class I
HNM MEDICAL — HNM STAINLESS, LLC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI 996d3207-e8f9-4d33-a70a-1e42d3af27c2 35 fields · synced Jun 9, 2026