Duns Number:961027315
Device Description: Astound Standard Surgical Gown, XL
Catalog Number
39545
Brand Name
CONVERTORS
Version/Model Number
39545
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 23, 2021
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
7d251767-41e3-43a4-a1a3-5dbd42266c68
Public Version Date
May 24, 2021
Public Version Number
7
DI Record Publish Date
June 28, 2016
Package DI Number
50630140012295
Quantity per Package
18
Contains DI Package
00630140012290
Package Discontinue Date
May 23, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |