Duns Number:108999095
Device Description: Electronic Scope-658,Adult, Metallic Ceil Blue
Catalog Number
658MCB
Brand Name
Adscope®
Version/Model Number
658MCB
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162589,K162589
Product Code
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
63d55d3f-9bde-4654-9e8f-939b503629fd
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
March 31, 2017
Package DI Number
00634782584719
Quantity per Package
3
Contains DI Package
00634782083328
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |