ETHICON

Basic Information

• Brand Name: ETHICON
• Primary DI: 10705031462571
• Version / Model: VSTL35
• Catalog Number: VSTL35
• 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: 2
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 093856ec-6f96-42df-83f7-7ae2ff44df1c

Device Description

Laparoscopic Dual Rigid 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
52751	Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use	A long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access 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 [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may 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	20705031462578	GS1	BOX	3	In Commercial Distribution
Primary	10705031462571	GS1
Package	30705031462575	GS1	CASE	72	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK190324	0