Duns Number:929236305
Device Description: Dry Tips Saliva Absorbent, X-Small
Catalog Number
292438
Brand Name
Dry Tips
Version/Model Number
292438
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KHR
Product Code Name
ABSORBER, SALIVA, PAPER
Public Device Record Key
8ef63236-ea02-44f7-ac9c-1bd70105e685
Public Version Date
October 05, 2022
Public Version Number
5
DI Record Publish Date
December 08, 2020
Package DI Number
10789594000999
Quantity per Package
50
Contains DI Package
00789594000992
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 43 |