Graether Micro Iris Retractor

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: GRAETHER MICRO IRIS RETRACTOR FDA UDI
Generic Name: Intraocular retractor, reusable FDA UDI
Device Name: GRAETHER MICRO IRIS RETRACTOR WITH COLLAR BUTTON ANGLED TIP FDA UDI
Model / Reference: 12-5210 FDA UDI
Description: GRAETHER MICRO IRIS RETRACTOR WITH COLLAR BUTTON ANGLED TIP FDA UDI

Identifiers

Catalog Number: 12-5210 FDA UDI
Primary DI / UDI-DI: 00192896013629 FDA UDI
FDA Product Code: HNI FDA UDI
GMDN Term: Intraocular retractor, 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

Category: Intraocular retractor, reusable

Graether Micro Iris Retractor by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Intraocular retractor, reusable.

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Hayden Medical — Hayden Medical Inc · Class I
GRAETHER IRIS RETRACTOR ANGLED — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Iris Retractor — Katena Products, Inc. · Class I
Walcott Rx Products — Walcott Rx Product Inc · Class I

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: Sontec Instruments, Inc.

Sources (1)

FDA UDI 59893964-c622-4c7d-9733-01fc001124ed 35 fields · synced May 31, 2026