Duns Number:065807495
Device Description: Disposable Surgical Gown - Level 3, Small, Blue
Catalog Number
DSG.SMS.L3.S.BLU
Brand Name
StringKing
Version/Model Number
20212
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)
-
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
9533b282-304f-4d74-97f4-726b5ec61d33
Public Version Date
December 17, 2021
Public Version Number
2
DI Record Publish Date
August 03, 2021
Package DI Number
30195376202125
Quantity per Package
25
Contains DI Package
10195376202121
Package Discontinue Date
-
Package Status
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |