Integra® Miltex®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: Integra® Miltex® FDA UDI
Generic Name: Ophthalmic surgical probe, reusable FDA UDI
Device Name: Integra® Miltex® Wecker Iris Spatula, 5-1/8", Malleable, Silver, 2.3mm x 32mm Blade FDA UDI
Model / Reference: 18-584 FDA UDI
Description: Integra® Miltex® Wecker Iris Spatula, 5-1/8", Malleable, Silver, 2.3mm x 32mm Blade FDA UDI

Identifiers

Catalog Number: 18-584 FDA UDI
Primary DI / UDI-DI: 10381780506119 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Ophthalmic surgical probe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

Dimensions & Sizes

Size: Width — 2.3 Millimeter FDA UDI
Length — 32 Millimeter FDA UDI

Category: Ophthalmic surgical probe, 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 d118f6a1-f310-441c-bf89-b68fce49470f 36 fields · synced Jun 9, 2026