FDA.reportPublic FDA data

DURAFIBER Ag PRO 10x12cm

Primary DI
15059884010935
Brand
DURAFIBER Ag PRO 10x12cm
Company
SPECIALITY FIBRES AND MATERIALS LIMITED
Model
FV001021
Catalog number
66027682
Device description
Wound Dressing with Antimicrobial Silver and Strengthening Cellulose Fiber
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
15059884010935PackageGS110In Commercial Distribution
05059884010938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505988401093515059884010935
05059884010938050598840109385059884010938

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
219041423
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059884010938DURAFIBER Ag PRO 10x12cmFV001021660276822026-02-09
05059884010945DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
05059884010952DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
05059884010969DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
05059884010976DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05059884010921DURAFIBER Ag PRO 10x10cmFV001020660276782026-02-09
15059884010942DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
15059884010959DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
15059884010966DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
15059884010973DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05060786987549Skinsafe Plus AgSkinsafe Plus Ag 120 5x5FT6506662023-11-14
05060786987556Skinsafe Plus AgSkinsafe Plus Ag 120 10x12.5FT6506672023-11-14
05060786981462Suprasorb ASuprasorb A L130 10x10cm204412024-05-22
05060786981479Suprasorb ASuprasorb A L130 10x12.5cm309902024-05-22
05060786981486Suprasorb ASuprasorb A L130 10x20cm204422024-05-22
05060786981493Suprasorb ASuprasorb A L130 2x30cm204452024-05-22
05060786981509Suprasorb ASuprasorb A L130 5x5cm204402024-05-22
05059884010365Skinsafe PlusSkinsafe Plus 120 5x5FP6506642023-11-14
05059884010372Skinsafe PlusSkinsafe Plus 120 10x12.5FP6506652023-11-14

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