Duns Number:965417181
Catalog Number
2211
Brand Name
PullUp Probe Cover Kit
Version/Model Number
2211
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
K970893,K970893
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
c05db419-e692-4758-91f5-01dcfda4aead
Public Version Date
May 17, 2021
Public Version Number
2
DI Record Publish Date
July 13, 2018
Package DI Number
10841912105653
Quantity per Package
24
Contains DI Package
00841912105656
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 451 |