Duns Number:130599421
Device Description: Ophthalmic Drape Incise with Single Fluid Pouch, Embossed Plastic 48 x 51 In.
Catalog Number
OPD1061NS
Brand Name
Atlanta Healthcare Services OcuDrape®
Version/Model Number
10852171007404
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
K854613,K854613
Product Code
HMT
Product Code Name
Drape, patient, ophthalmic
Public Device Record Key
3d8c3451-ab25-459b-b472-aefc913f811b
Public Version Date
August 31, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-