SiliGentle AG Silver Silicone Foam Dressing

Basic Information

• Brand Name: SiliGentle AG Silver Silicone Foam Dressing
• Primary DI: 00616784308616
• Version / Model: 3086
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-24
• Public Version: 1
• Public Version Date: 2022-05-02
• Public Version Status: New
• Public Device Record Key: effe89ce-5574-41c4-b72b-38d9a9450c94

Device Description

SiliGentle AG Silver Silicone Foam Dressing, Bordered, 6" x 6" (15cm x 15cm), High Absorbency, For Wound Stages 2,3,4

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47045	Cavity-wound management dressing, antimicrobial	A non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent), and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616784308616	GS1
Package	00616784308623	GS1	Box	10	In Commercial Distribution
Package	00616784308630	GS1	Case	5	In Commercial Distribution