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Integra® Miltex®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
Integra® Miltex® FDA UDI
Generic Name
Gastro-urological director FDA UDI
Device Name
Integra® Miltex® Grooved Director 6-1/4", with Plain Point and Tongue Tie FDA UDI
Model / Reference
1074 FDA UDI
Description
Integra® Miltex® Grooved Director 6-1/4", with Plain Point and Tongue Tie FDA UDI

Identifiers

Catalog Number
10-74 FDA UDI
Primary DI / UDI-DI
10381780357858 FDA UDI
FDA Product Code
FGM FDA UDI
GMDN Term
Gastro-urological director FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Gastro-urological director

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

Similar devices

Also classified as Gastro-urological director.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI ea648d50-f3d6-484c-87f6-3cc032b45b06 35 fields · synced Jun 9, 2026