Duns Number:006309355
Device Description: Young Rubber Damn Frame Kit, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in Young Rubber Damn Frame Kit, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in.) (12.8 cm x 10.4 cm), neckbands, template and manual
Catalog Number
177701
Brand Name
Young
Version/Model Number
177701
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
EJE
Product Code Name
FRAME, RUBBER DAM
Public Device Record Key
c1909848-e5a3-4fd4-97fd-f0e78e4adf81
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302731777013
Quantity per Package
1
Contains DI Package
00302731777016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |