Duns Number:081057389
Device Description: BACK TABLE COVER, FAN FOLD, 70 IN. X 110 IN./177 CM X 279 CM
Catalog Number
-
Brand Name
Halyard
Version/Model Number
42226
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"
Yes
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
K083234,K083234
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
697d5bae-fabd-435b-8401-e52fbe80ee36
Public Version Date
October 17, 2018
Public Version Number
4
DI Record Publish Date
December 04, 2015
Package DI Number
30680651422263
Quantity per Package
36
Contains DI Package
10680651422269
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 1044 |