SURGICEL

Basic Information

• Brand Name: SURGICEL
• Primary DI: 10705031237513
• Version / Model: 3123SPEA
• Catalog Number: 3123SPEA
• Company Name: ETHICON, LLC
• Labeler DUNS: 829465157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-13
• Public Version: 3
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 34030087-c4ed-4fd9-814e-2efa4ff785d0

Device Description

Endoscopic 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
LMG	Agent, absorbable hemostatic, non-collagen based	General, Plastic Surgery	878.4490	3

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	20705031237510	GS1	BOX	5	In Commercial Distribution
Primary	10705031237513	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
N12159	047

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged