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Scleral Marker

FDA UDI

Class I (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name
Scleral Marker FDA UDI
Generic Name
Scleral marker, reusable FDA UDI
Device Name
GASS SCLERAL MARKER FDA UDI
Model / Reference
K1-7790 FDA UDI
Description
GASS SCLERAL MARKER FDA UDI

Identifiers

Catalog Number
K1-7790 FDA UDI
Primary DI / UDI-DI
00841668100875 FDA UDI
FDA Product Code
HMQ FDA UDI
GMDN Term
Scleral marker, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4570 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Scleral marker, reusable

Scleral Marker by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scleral marker, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Katena Products, Inc.

Sources (1)

  • FDA UDI 27f0351b-ee4a-4426-97ce-48417b029a77 35 fields · synced Jun 12, 2026