FDA.report

SiliGentle AG Silver Silicone Foam Dressing

Primary DI
00616784308319
Brand
SiliGentle AG Silver Silicone Foam Dressing
Company
DYNAREX CORPORATION
Model
3083
Device description
SiliGentle AG Silver Silicone Foam Dressing, Non-Bordered, 6" x 6" (15cm x 15cm), High Absorbency, For Wound Stages 2,3,4
Published
2022-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784308326PackageGS110In Commercial Distribution
00616784308333PackageGS15In Commercial Distribution
00616784308319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784308326006167843083266167843083260616784308326
00616784308333006167843083336167843083330616784308333
00616784308319006167843083196167843083190616784308319

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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