Soft K-Rette

Basic Information

• Brand Name: Soft K-Rette
• Primary DI: 00860275000354
• Version / Model: SFT-4500
• Catalog Number: SFT-4500
• Company Name: HISTOLOGICS, LLC
• Labeler DUNS: 023001257
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-10
• Public Version: 1
• Public Version Date: 2019-11-18
• Public Version Status: New
• Public Device Record Key: 529e604b-dce2-4d6a-8222-078a3d2216ab

Device Description

Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.

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
FZS	Curette, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58294	Wound debridement pad	A sterile device intended to be used for the manual debridement of wounds (e.g., diabetic foot ulcers, venous ulcers, arterial ulcers, pressure ulcers, bedsores) by gentle wiping of the wound surface to remove unhealthy tissue (e.g., exudate, slough, cellular debris) to promote healing. It typically consists of a swab-like pad with the side to be used for debridement made of synthetic polymer (e.g., monofilament polyester) fibres. It may be soaked in water/saline before use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860275000351	GS1	Case	250	In Commercial Distribution
Primary	00860275000354	GS1

Customer Contacts

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