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Surgical Marking Pen

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name
Surgical Marking Pen FDA UDI
Generic Name
Corneal marker, single-use FDA UDI
Device Name
Surgical Marking Pen, Fine Tip, Gentian Violet. FDA UDI
Model / Reference
0442 FDA UDI
Description
Surgical Marking Pen, Fine Tip, Gentian Violet. FDA UDI

Identifiers

Primary DI / UDI-DI
00845819000472 FDA UDI
FDA Product Code
FZZ FDA UDI
GMDN Term
Corneal marker, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

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
Radiation Sterilization FDA UDI

Category: Corneal marker, single-use

Surgical Marking Pen by OASIS Medical, Inc. — Class I — 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
OASIS Medical, Inc.

Sources (1)

  • FDA UDI 11a00c46-54ef-4e30-a3c0-5d948ec824b2 34 fields · synced Jun 9, 2026