Foam 10x12.5cm Pack 1

Basic Information

• Brand Name: Foam 10x12.5cm Pack 1
• Primary DI: 00040565125909
• Version / Model: 66801021
• Catalog Number: 66801021
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-15
• Public Version: 4
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: e4725718-1a3c-47f8-814d-5a9df00eaa06

Device Description

NPWT Foam Wound Dressings for use with RENASYS and PICO NPWT Systems. 10cmx13cm

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00040565125909	GS1
Package	30040565125900	GS1	case	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K142979	000