Duns Number:130599421
Device Description: OR Surgical Gown, Sterile, Large, non-reinforced Level III with absorbent towel
Catalog Number
SORG102LG
Brand Name
Atlanta Healthcare Services OcuDrape®
Version/Model Number
10851736007880
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
K931562,K931562
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
24814e8a-6d31-4667-b12d-7cfe7556833e
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
November 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-