Duns Number:039612668
Catalog Number
-
Brand Name
Uline Bullet Earplugs Refill
Version/Model Number
S-24617
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
76c9134a-0a5a-40c8-8a50-fa22e363f693
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 24, 2022
Package DI Number
30850015055233
Quantity per Package
10
Contains DI Package
10850015055291
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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 2 |