ETHICON

Basic Information

• Brand Name: ETHICON
• Primary DI: 10705031230132
• Version / Model: 3921S
• Catalog Number: 3921S
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 7
• Public Version Date: 2023-03-16
• Public Version Status: Update
• Public Device Record Key: 93268a0d-942e-46e5-8722-4dfaceedf977
• Distribution End Date: 2023-03-15

Device Description

Evicel Airless Spray Accessory

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	20705031230139	GS1	BOX	10	Not in Commercial Distribution	2023-03-15
Primary	10705031230132	GS1
Package	30705031230136	GS1	CASE	10	Not in Commercial Distribution	2023-03-15

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK140093	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit