Duns Number:062388929
Device Description: Earloop procedure mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 1, Earloop procedure mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 1, non-sterile, case of 300 ea
Catalog Number
5301
Brand Name
Strong Manufacturers
Version/Model Number
5301
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K214087,K214087
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
fd746893-1a99-4aad-92f4-b8847eeafc2c
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
Package DI Number
10853927007730
Quantity per Package
300
Contains DI Package
00853927007733
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 | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |