Duns Number:014982953
Device Description: Bell Ear Plug Dispenser Refill, 33dB Noise Reduction Rating
Catalog Number
MAX-LS4E
Brand Name
Howard Leight
Version/Model Number
Leight Source
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
-
Product Code
EWD
Product Code Name
Protector, Hearing (Insert)
Public Device Record Key
a8784407-97b4-4d84-9311-b3d567b28faa
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 38 |