Key Surgical Guidewire

Basic Information

• Brand Name: Key Surgical Guidewire
• Primary DI: 00849771039297
• Version / Model: EN10450B
• Catalog Number: EN10450B
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-07
• Public Version: 4
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: bb7ae267-82c1-4520-8fcd-ee6ba18262cf
• Distribution End Date: 2023-06-27

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46691	Gastro-urological guidewire, single-use	A sterile 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00849771039303	GS1	Box	10	Not in Commercial Distribution	2023-06-27
Primary	00849771039297	GS1
Package	10849771039300	GS1	Case	10	Not in Commercial Distribution	2023-06-27

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Guidewire Length	4500	Millimeter
Guidewire Diameter	0.035	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius