Duns Number:989214291
Device Description: Halo One Thin-Walled Guiding Sheath 5F x 10cm
Catalog Number
HAL510F
Brand Name
Halo One™ Thin-Walled Guiding Sheath
Version/Model Number
HAL510F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 18, 2017
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
-
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
97e1d94b-6dc0-4b87-8b1c-42ad1244f9bd
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
June 10, 2016
Package DI Number
10801741129695
Quantity per Package
5
Contains DI Package
00801741129698
Package Discontinue Date
January 18, 2017
Package Status
Not in Commercial Distribution
Package Type
CA
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 |