ETHICON

Basic Information

• Brand Name: ETHICON
• Primary DI: 10705031462533
• Version / Model: VSTAS1E
• Catalog Number: VSTAS1E
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 4
• Public Version Date: 2023-11-16
• Public Version Status: Update
• Public Device Record Key: 25783399-8fe8-4f62-b5f7-1c2c27441d9e

Device Description

VISTASEAL DUAL APPLICATOR

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
MZM	Fibrin sealant preparation device	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64222	Haematological concentrate/haemostatic agent applicator cannula, open-surgery	A flexible or rigid tube intended to be used during an open surgical procedure for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe/plunger [not included]. It may have a single channel, to administer one product, or dual channels for co-administration of two different agents simultaneously; a channel for connection to a gas pump for spraying may also be incorporated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031462530	GS1	BOX	15	Not in Commercial Distribution	2023-11-15
Primary	10705031462533	GS1
Package	30705031462537	GS1	CASE	120	Not in Commercial Distribution	2023-11-15
Package	30705031466931	GS1	CASE	120	In Commercial Distribution
Package	20705031466934	GS1	BOX	3	In Commercial Distribution

Customer Contacts

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