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Scleral Markers

FDA UDI

Class II (US FDA UDI)

by Sterimedix Limited

Identity

Trade Name
Scleral Markers FDA UDI
Generic Name
Corneal marker, single-use FDA UDI
Device Name
3.5 x 4mm Scleral Marker FDA UDI
Model / Reference
7500NS-02/100/Y FDA UDI
Description
3.5 x 4mm Scleral Marker FDA UDI

Identifiers

Catalog Number
M7500NS FDA UDI
Primary DI / UDI-DI
55056030402291 FDA UDI
FDA Product Code
MED FDA UDI
GMDN Term
Corneal marker, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6885 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Corneal marker, single-use

Scleral Markers by Sterimedix Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corneal marker, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterimedix Limited

Sources (1)

  • FDA UDI 89068e38-ef57-403d-a675-2728d8701d07 34 fields · synced Jun 8, 2026