FDA.reportPublic FDA data

SiliGentle AG Silver Silicone Foam Dressing

Primary DI
00616784308517
Brand
SiliGentle AG Silver Silicone Foam Dressing
Company
Dynarex Corporation
Model
3085
Device description
"SiliGentle AG Silver Silicone Foam Dressing, Bordered, 4"" x 4"" (10cm x 10cm), High Absorbency, For Wound Stages 2,3,4"
Published
2022-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784308524PackageGS110In Commercial Distribution
00616784308531PackageGS15In Commercial Distribution
00616784308517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784308524006167843085246167843085240616784308524
00616784308531006167843085316167843085310616784308531
00616784308517006167843085176167843085170616784308517

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, antimicrobialA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1

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