Integra® Miltex® 012-15102

by Integra LifeSciences Production Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10381780482857 UDI-DI	Date3 Jul 2018Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Integra® Miltex®
Generic Name: Manual endodontic file/rasp, single-use
Model / Ref / Catalog: 012-15102

Primary DI / UDI-DI: 10381780482857
FDA Product Code: EKS
GMDN Term: Manual endodontic file/rasp, single-use

Device Class: Class I
Regulation Number: 872.4565
GUDID distribution status: Not in Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No