Duns Number:084527241
Catalog Number
-
Brand Name
HANA ANTERIOR HIP UPPER STERILE DRAPE
Version/Model Number
6855AUD-1
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
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
6d3e12e9-de14-4cec-a094-dc9a868c196a
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
Package DI Number
10842430108867
Quantity per Package
6
Contains DI Package
00842430108860
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 | 1076 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |