Duns Number:007914906
Device Description: GNP EAR PLUG FOAM QUIET PLEASE 10PAIR 6/72
Catalog Number
-
Brand Name
GOOD NEIGHBOR PHARMACY
Version/Model Number
F408-150GP
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
c6ce7952-d953-4d6c-86ff-dd7ebc378bb8
Public Version Date
August 08, 2022
Public Version Number
3
DI Record Publish Date
September 03, 2020
Package DI Number
20025715028501
Quantity per Package
6
Contains DI Package
00087701412394
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |