Duns Number:989214291
Device Description: Halo One Thin-Walled Guiding Sheath 5F x 45cm
Catalog Number
HAL545
Brand Name
Halo One™ Thin-Walled Guiding Sheath
Version/Model Number
HAL545
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
K161183
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
8a60a508-a0d8-4147-9583-158d08be0704
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
June 10, 2016
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. | 228 |
3 | A medical device with high risk that requires premarket approval | 42 |