Duns Number:134472476
Device Description: AAMI3, SRG GWN, SET IN SLV, ST, S/M
Catalog Number
382959
Brand Name
Regard™
Version/Model Number
A3SRGSTSM-REG
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
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
0b02afd1-5f46-41ce-a591-dac92dee067b
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 10, 2020
Package DI Number
10326053117555
Quantity per Package
32
Contains DI Package
00326053117558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 558 |