AccessGUDID - DEVICE: Halo One™ Thin-Walled Guiding Sheath (00801741111549)

GUDID

Device Identifier (DI) Information

Brand Name: Halo One™ Thin-Walled Guiding Sheath
Version or Model: HAL545
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HAL545
Company Name: CLEARSTREAM TECHNOLOGIES LIMITED

Primary DI Number: 00801741111549
Issuing Agency: GS1
Commercial Distribution End Date: January 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 989214291 *Terms of Use

Device Description: Halo One Thin-Walled Guiding Sheath 5F x 45cm

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Inner Diameter, 5 French
Device Size Text, specify: Shaft Length, 45 centimeter

Device Record Status

Public Device Record Key: 8a60a508-a0d8-4147-9583-158d08be0704
Public Version Date: January 25, 2024
Public Version Number: 8
DI Record Publish Date: June 10, 2016