Duns Number:481597719
Catalog Number
1700503-001
Brand Name
RAPIDO Micromotor + Cable
Version/Model Number
1700503
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
-
Product Code
ERL
Product Code Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Public Device Record Key
c051278d-85f8-48ad-8af7-6272e47f64c1
Public Version Date
February 07, 2019
Public Version Number
1
DI Record Publish Date
January 07, 2019
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 69 |