DERMABOND PRINEO

Basic Information

• Brand Name: DERMABOND PRINEO
• Primary DI: 10705031240421
• Version / Model: CLR422US
• Catalog Number: CLR422US
• Company Name: ETHICON, LLC
• Labeler DUNS: 829465157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 504b4a8f-e537-4048-bb72-2a729a4a4dd9

Device Description

Dermabond Prineo Skin Closure System

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
OMD	Cutaneous tissue adhesive with mesh	General, Plastic Surgery	878.4011	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46880	Wound closure set, topical	A collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031240428	GS1	BOX	2	In Commercial Distribution
Primary	10705031240421	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163645	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Away from moisture, direct heat, anddirect light
• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius