Duns Number:603420183
Device Description: RD180® SP™ - THE RUNNING DEVICE®Base Package Type - EachEach sterile package contains (1) RD180® SP™ - THE RUNNING DEVICE®Base Package Type - EachEach sterile package contains (1) single patient use disposable RD180® SP™ (Single Port) Suturing Device.
Catalog Number
021450
Brand Name
RD180® - THE RUNNING DEVICE®
Version/Model Number
021450
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100593,K100593
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
d857b77b-3f82-49e4-9f5e-4212bbdc39c3
Public Version Date
December 04, 2020
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
10850200006206
Quantity per Package
6
Contains DI Package
00850200006209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |