Duns Number:078686903
Device Description: DD-II 770 Display Digital Doppler, 5MHz vascular probe
Catalog Number
DD-770-D5
Brand Name
DigiDop
Version/Model Number
DD-770-D5
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
K090465
Product Code
JAF
Product Code Name
Monitor, Ultrasonic, Nonfetal
Public Device Record Key
24bb28eb-f1ea-4b05-8c04-743238857fa0
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 91 |