Duns Number:130599421
Device Description: Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22" Tape Strip., single use, Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22" Tape Strip., single use, Sterile
Catalog Number
DRA503
Brand Name
Atlanta Healthcare Services OcuDrape®
Version/Model Number
10852171007954
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
87ee4640-7a14-49a3-b9cf-0ef9643fe7d7
Public Version Date
August 31, 2020
Public Version Number
3
DI Record Publish Date
October 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-