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Surgi-Sign

FDA UDI

Class I (US FDA UDI)

by Or-6, LLC

Identity

Trade Name
Surgi-Sign FDA UDI
Generic Name
Skin marking sticker FDA UDI
Device Name
A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure. For more information please visit www.surgisign.com FDA UDI
Model / Reference
1 FDA UDI
Description
A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure. For more information please visit www.surgisign.com FDA UDI

Identifiers

Catalog Number
SMS-Eye FDA UDI
Primary DI / UDI-DI
G047SMSEYE1 FDA UDI
FDA Product Code
FZZ FDA UDI
GMDN Term
Skin marking sticker 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Skin marking sticker

Surgi-Sign by Or-6, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin marking sticker.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Or-6, LLC

Sources (1)

  • FDA UDI f48ca49c-67c9-4f0f-81d9-b238a8b4642c 34 fields · synced May 30, 2026