Duns Number:003687733
Device Description: TIE FACEMASK, W/SHIELD & MAGIC ARCH, ANTIFOG STRIP, BLUE BULK PACK 100
Catalog Number
SHI BL 8101 SB
Brand Name
SHIELDMATE
Version/Model Number
SHI BL 8101 SB
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
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
9bcc806b-f850-42e6-9b98-88e3e01b93cf
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
November 03, 2016
Package DI Number
10817583020540
Quantity per Package
100
Contains DI Package
00817583020543
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 |