Duns Number:008965063
Device Description: Foam Earplugs 50 Pair 32 dB Noise Reduction Rating
Catalog Number
-
Brand Name
Walgreen's
Version/Model Number
877249
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
d0385640-7b28-4431-9052-d4137a44ca2c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
10311917200801
Quantity per Package
48
Contains DI Package
00311917200804
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 | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |