Duns Number:025460908
Device Description: GOWN,SRI,XALT/SPECIALTY,L4,GRN,M
Catalog Number
SYN7882M
Brand Name
Medline
Version/Model Number
SYN7882M
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
-
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
57dfbb7d-6423-41c7-bb9c-3b27d7ad62a1
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
20888277419916
Quantity per Package
24
Contains DI Package
10888277419919
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |