AccessGUDID - DEVICE: Key Surgical Guidewire (00849771039297)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Guidewire
Version or Model: EN10450B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EN10450B
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771039297
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Hydrophilic Guidewire, Zebra-Coated, Straight Tip, 0.035-inch Diam, 4500mm L

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 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Temperature: between -10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Guidewire Length: 4500 Millimeter
Guidewire Diameter: 0.035 Inch

Device Record Status

Public Device Record Key: bb7ae267-82c1-4520-8fcd-ee6ba18262cf
Public Version Date: December 23, 2024
Public Version Number: 5
DI Record Publish Date: March 07, 2020