Duns Number:962519208
Device Description: Square Square Snap Electrodes - aggressive adhesion (not for use on infants)
Catalog Number
101605
Brand Name
Biologic
Version/Model Number
Disposable Electrodes
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
K030823,K031009,K073626,K073665,K083371,K111618,K112247,K121512,K122496,K141446,K030823,K031009,K073626,K073665,K083371,K111618,K112247,K121512,K122496,K141446
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
deb2da7c-3aac-4cf5-99f3-3bc3fbd646f6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |