Duns Number:965417181
Catalog Number
1042
Brand Name
PullUp Instrument Cover
Version/Model Number
1042
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
K970885,K970885
Product Code
MMP
Product Code Name
Cover, Barrier, Protective
Public Device Record Key
4977220b-e947-4f95-bd20-5ac535e831e0
Public Version Date
May 27, 2019
Public Version Number
1
DI Record Publish Date
May 17, 2019
Package DI Number
10841912106063
Quantity per Package
10
Contains DI Package
00841912106066
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 |