Duns Number:079767953
Device Description: Tissue/Poly Flat Stretcher Sheets/Drape Sheets, 40" x 90", Blue (25 Pack)
Catalog Number
ds4090x25
Brand Name
Avaline Medical NJ LLC
Version/Model Number
ds4090x25
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
-
Product Code
KME
Product Code Name
BEDDING, DISPOSABLE, MEDICAL
Public Device Record Key
ee37c492-6d8e-40a5-923f-1cd36bbad99b
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 263 |