Duns Number:006961700
Device Description: Up & Up Silicone Ear Plugs 8 pair with Case
Catalog Number
5924
Brand Name
Up & Up
Version/Model Number
245-09-0125
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
89e61ef3-e186-4372-9afb-de0a831bb564
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 24, 2018
Package DI Number
10756063059246
Quantity per Package
72
Contains DI Package
00756063059249
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |