Duns Number:003687733
Device Description: TIE MASK W/ SNAP ON SHIELD, BLUE 7 MIL.
Catalog Number
SHI5194T
Brand Name
Combo
Version/Model Number
SHI5194T
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
K882027,K882027,K882027
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
16f132ea-e223-41b5-899e-5cd213206a31
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
November 03, 2016
Package DI Number
20817583020516
Quantity per Package
4
Contains DI Package
10817583020519
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |