Duns Number:835465063
Device Description: CABLE 8253080 MINI SCREEN
Catalog Number
-
Brand Name
NA
Version/Model Number
8253080
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083124
Product Code
ETN
Product Code Name
STIMULATOR, NERVE
Public Device Record Key
f3a2a128-1ca6-4b6a-8311-1f4571087b00
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 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 | 665 |
2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
3 | A medical device with high risk that requires premarket approval | 6 |
U | Unclassified | 10 |