Duns Number:038730060
Device Description: 9X44 IMP STKT
Catalog Number
-
Brand Name
Tex-Care Medical
Version/Model Number
81170-944
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K955749
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
21d2a9fe-28a0-4ecd-a9bc-50e2a07a1f31
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
October 29, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 188 |
2 | A medical device with a moderate to high risk that requires special controls. | 40 |