Duns Number:134614411
Device Description: SCOUT Guide Sheath for use with SCOUT Surgical Guidance System
Catalog Number
SH-01
Brand Name
CIV-Flex™ Guide Sheath
Version/Model Number
SH-01
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"
Yes
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
K970513,K970513
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
9e13cff3-41e7-4596-8705-8416e266ecdc
Public Version Date
September 06, 2021
Public Version Number
2
DI Record Publish Date
January 21, 2021
Package DI Number
00841436120951
Quantity per Package
20
Contains DI Package
10841436120958
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |