← Back to catalogue

Schepens Orbital Retractor, Titanium

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name
Schepens Orbital Retractor, Titanium FDA UDI
Generic Name
Periocular/lacrimal retractor, hand-held, reusable FDA UDI
Device Name
Schepens Orbital Retractor, Titanium FDA UDI
Model / Reference
AS1-250T FDA UDI
Description
Schepens Orbital Retractor, Titanium FDA UDI

Identifiers

Catalog Number
AS1-250T FDA UDI
Primary DI / UDI-DI
08175700104500 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Periocular/lacrimal retractor, hand-held, reusable

Schepens Orbital Retractor, Titanium by Aurora Surgical, Llc — 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

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

Manufacturer

Manufacturer
Aurora Surgical, Llc

Sources (1)

  • FDA UDI 42c7e286-fe9c-4597-90bf-029ad765f88a 34 fields · synced Jun 8, 2026