AccessGUDID - DEVICE: Zebra Guidewire for Urinary Tract (06976055233066)

GUDID

Device Identifier (DI) Information

Brand Name: Zebra Guidewire for Urinary Tract
Version or Model: UOW-38150S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SF.UB11.B15
Company Name: SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06976055233066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618556012 *Terms of Use

Device Description: The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the entire wire) with no coating on the surface and a soft tip containing a stainless steel spring; The mixed type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the part except the distal end), and a polyurethane containing tungsten (PU) cladding with hydrophilic coating on the surface (applied to the prat of distal end 60mm).

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
46691	Gastro-urological guidewire, single-use	A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCY	Endoscopic Guidewire, Gastroenterology-Urology

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c725533-bc15-4dda-b97c-6fc8e8c211ef
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: April 24, 2024