Duns Number:057647005
Device Description: Original G-Ring, Long Length Tines
Catalog Number
G200-1
Brand Name
Composi-Tight®
Version/Model Number
G200-1
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEP
Product Code Name
Retainer, Matrix
Public Device Record Key
fd928b90-a6f3-4bfb-a8c5-45ac7c1f331f
Public Version Date
May 04, 2020
Public Version Number
1
DI Record Publish Date
April 24, 2020
Package DI Number
10810038094578
Quantity per Package
3
Contains DI Package
00810038094571
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
G200
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 436 |