Flieringa Scleral Fixation Ring, 13mm

FDA UDI

Class I (US FDA UDI)

by Katalyst Surgical, Llc

Identity

Trade Name: Flieringa Scleral Fixation Ring, 13mm FDA UDI
Generic Name: Eyeball fixation instrument, reusable FDA UDI
Device Name: Flieringa Scleral Fixation Ring, 13mm FDA UDI
Model / Reference: 8800-13 FDA UDI
Description: Flieringa Scleral Fixation Ring, 13mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00840096207439 FDA UDI
FDA Product Code: HNH FDA UDI
GMDN Term: Eyeball fixation instrument, 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

Category: Eyeball fixation instrument, reusable

Flieringa Scleral Fixation Ring, 13mm by Katalyst Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Eyeball fixation instrument, reusable.

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TWIST HOOK RIGHT — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, 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: Katalyst Surgical, Llc

Sources (1)

FDA UDI b1460201-0dd4-4fde-810f-66f84ed61911 33 fields · synced May 30, 2026