Duns Number:631770658
Device Description: T/Fast Gloves XS Child
Catalog Number
-
Brand Name
Tubifast®
Version/Model Number
5922
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
f9d424c9-b70d-48a9-b219-9cb8bd5a2683
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
07332551870690
Quantity per Package
6
Contains DI Package
07332551870706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 212 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |
U | Unclassified | 18 |