Duns Number:316305242
Catalog Number
-
Brand Name
Gamma Finder Sterile Sleeve
Version/Model Number
GMSLV001-50
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"
-
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
IZD
Product Code Name
Probe, Uptake, Nuclear
Public Device Record Key
7c3f9230-d0c3-458f-ad7b-ca4a8d50de15
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 25, 2016
Package DI Number
04056702004187
Quantity per Package
50
Contains DI Package
04056702004170
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |