Duns Number:008965063
Device Description: Silicone Earplugs Orange 6 Pair 22 dB Noise Reduction Rating
Catalog Number
-
Brand Name
walgreen's
Version/Model Number
886171
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
-
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
1e3f096d-39f7-4405-ac77-a4112be9fa07
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
10311917200962
Quantity per Package
144
Contains DI Package
00311917200965
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 |