ETHICON

Basic Information

• Brand Name: ETHICON
• Primary DI: 10705031047822
• Version / Model: PCP40
• Catalog Number: PCP40
• Company Name: Johnson & Johnson International Inc.
• Labeler DUNS: 372587696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 3
• Public Version Date: 2019-07-24
• Public Version Status: Update
• Public Device Record Key: b66a3d23-7d01-431f-a685-aa99cb3f4067

Device Description

Polymer Pledget PTFE Suture Butress

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: Yes
• 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
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33519	Suture retention device	A device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031047829	GS1	BOX	36	In Commercial Distribution
Primary	10705031047822	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius