Duns Number:160990313
Device Description: Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 mon Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization.
Catalog Number
GIS-46S
Brand Name
Spot Ex CE Endoscopic Tattoo
Version/Model Number
GIS-46
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NGB
Product Code Name
Test, Glycosylated Hemoglobin, Over The Counter
Public Device Record Key
509c8c66-0d11-4198-8bba-4e56ddfad3cd
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
Package DI Number
10893029002196
Quantity per Package
10
Contains DI Package
00893029002199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |