Duns Number:003375805
Device Description: 8" x 54" IMPERVIOUS NON-STER
Catalog Number
-
Brand Name
Albahealth
Version/Model Number
CN5408009990902
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
K792357,K792357
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
998cdc1c-1ee7-45aa-936b-881fe776ab25
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
50073614779452
Quantity per Package
56
Contains DI Package
00073614779457
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. | 300 |