Duns Number:809994163
Device Description: Soft Foam Earplugs 10 Pairs
Catalog Number
-
Brand Name
Leader
Version/Model Number
81025
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)
Yes
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
a0256a74-fac7-4dd6-935c-ff8e5b389539
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 21, 2019
Package DI Number
10096295133889
Quantity per Package
1
Contains DI Package
00096295133882
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Unit
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 4 |