Duns Number:103169095
Device Description: Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900" tip to tip, Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900" tip to tip, 500 clips per bag (GIC190-5). 2 bags of 500 clips per case (GIC190-10).
Catalog Number
-
Brand Name
Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900"
Version/Model Number
GIC190
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
3c9fa57d-1dab-43a6-8eb6-f60316e80925
Public Version Date
September 19, 2022
Public Version Number
4
DI Record Publish Date
March 31, 2022
Package DI Number
10843356101840
Quantity per Package
2
Contains DI Package
00843356101843
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 | 146 |