ENVOY

Basic Information

• Brand Name: ENVOY
• Primary DI: 10886704031802
• Version / Model: 670-260-90B
• Catalog Number: 67026090B
• Company Name: Cerenovus, Inc.
• Labeler DUNS: 607846297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 10
• Public Version Date: 2023-11-13
• Public Version Status: Update
• Public Device Record Key: 3ddda54c-e714-4c0c-ac87-84acebc6aa06

Device Description

ENVOY XB Guiding Catheter STR 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DQY	CATHETER, PERCUTANEOUS	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704031802	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093184	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL, DARK, DRY PLACE
• Type: Handling Environment Temperature
• Temperature Range: High: 130 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 130 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 54 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 54 Degrees Celsius