← Back to catalogue

Spot Ex CE Endoscopic Tattoo

FDA UDI

Class II (US FDA UDI)

by GI Supply, Inc.

Identity

Trade Name
Spot Ex CE Endoscopic Tattoo FDA UDI
Generic Name
Tissue marking ink FDA UDI
Device Name
Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization. FDA UDI
Model / Reference
GIS-46 FDA UDI
Description
Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization. FDA UDI

Identifiers

Catalog Number
GIS-46S FDA UDI
Primary DI / UDI-DI
00893029002199 FDA UDI
FDA Product Code
NGB FDA UDI
GMDN Term
Tissue marking ink FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7470 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

No

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

Yes

FDA UDI

Category: Tissue marking ink

Spot Ex CE Endoscopic Tattoo by GI Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue marking ink.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
GI Supply, Inc.

Sources (1)

  • FDA UDI 509c8c66-0d11-4198-8bba-4e56ddfad3cd 36 fields · synced May 30, 2026