ETHICON

Basic Information

• Brand Name: ETHICON
• Primary DI: 10705031007215
• Version / Model: 6371339020
• Catalog Number: 6371339020
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-15
• Public Version: 7
• Public Version Date: 2023-03-15
• Public Version Status: Update
• Public Device Record Key: d371bc1a-4f11-4ce5-9c1e-a29b559b031b
• Distribution End Date: 2023-03-14

Device Description

EVICEL 1/2 ML DEVICE

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
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47186	Haematological concentrate/haemostatic agent applicator	A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705031007215	GS1

Customer Contacts

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