RenoCare Spot

Basic Information

• Brand Name: RenoCare Spot
• Primary DI: 08800048007731
• Version / Model: HD14EN46
• Company Name: T&L Co.,Ltd.
• Labeler DUNS: 694747496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-10
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 2e813211-03f5-4827-a9ba-5125e33d9393

Device Description

RenoCareTM Hydrocolloid Band has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a breathable polyurethane film backing. Hydrocolloid matrix rapidly absorbs exudates to form a cohesive gel providing significantly higher absorbency than the leading competitive hydrocolloid. In addition to excellent absorbency, the breathable polyurethane film backing provides a consistently high rate of moisture vapor transmission. Together, these features ensure an optimal moist wound environment, minimize the chance for damage to healthy peri-wound skin and provide cost-effective wear time for up to seven days.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43186	Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800048007731	GS1