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Avalign

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name
Avalign FDA UDI
Generic Name
Periocular/lacrimal retractor, hand-held, reusable FDA UDI
Device Name
Schepens Orbital Retractor OL 155mm(6 1/8") FDA UDI
Model / Reference
VM91-7386 FDA UDI
Description
Schepens Orbital Retractor OL 155mm(6 1/8") FDA UDI

Identifiers

Primary DI / UDI-DI
00190776285531 FDA UDI
FDA Product Code
HNI FDA UDI
GMDN Term
Periocular/lacrimal retractor, hand-held, 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

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: Periocular/lacrimal retractor, hand-held, reusable

Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Periocular/lacrimal retractor, hand-held, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AVALIGN TECHNOLOGIES, Inc.

Sources (1)

  • FDA UDI c93e5298-2bfd-4dff-8a13-6d851ac3c0cc 34 fields · synced May 29, 2026