Fixation Ring

FDA UDI

Class I (US FDA UDI)

by Charmant Inc.

Identity

Trade Name: Fixation Ring FDA UDI
Generic Name: Eyeball fixation instrument, reusable FDA UDI
Model / Reference: 37-0030 FDA UDI

Identifiers

Primary DI / UDI-DI: 00883475708479 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

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

Fixation Ring by Charmant Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyeball fixation instrument, reusable.

Flieringa Scleral Fixation Ring, 13mm — KATALYST SURGICAL, LLC · Class I
Walcott Rx Products — Walcott Rx Product Inc · Class I
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Rumex — Rumex International Co. · Class I
Flieringa Scleral Fixation Ring, 17mm Diameter — AURORA SURGICAL, LLC · Class I
FINE-THORNTON FIXATION RING 13MM — Katena Products, Inc. · Class I
Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
TWIST HOOK RIGHT — Katena Products, 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: Charmant Inc.

Sources (1)

FDA UDI e8b16e26-a5a6-45b7-bcac-95ed116a3993 32 fields · synced May 30, 2026