FDA.reportPublic FDA data

Silflex

Primary DI
05060031472943
Brand
Silflex
Company
BRIGHTWAKE LIMITED
Model
CR3923
Device description
Soft silicone wound contact layer 8 cm X 10 cm. A wound contact layer made from polyester mesh and coated with Silfix soft silicone. Silflex is designed to gently adhere to the skin surrounding a wound and not to the wound bed. This is an atraumatic dressing designed to minimise the pain and trauma associated with dressing change. The dressing’s large perforations allow for the passage of exudate and irrigation of wound.
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060031472950PackageGS110In Commercial Distribution
05060031472967PackageGS130In Commercial Distribution
05060031472943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031472950050600314729505060031472950
05060031472967050600314729675060031472967
05060031472943050600314729435060031472943

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width8Centimeter

Contacts#

Phone, Email table
PhoneEmail
+441623751500info@advancis.co.uk

Regulatory Flags#

DUNS number
226502201
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060031485424Tracoe Purofoam-T LargeCR45552025-10-08
05060031485462Tracoe Purofoam-T Large LiteCR45562025-10-08
05060031485509Tracoe Purofoam-T SmallCR45572025-10-08
05060031482645Eclypse Non-BackedCR45172025-08-07
05060031482683Eclypse Non-BackedCR45182025-08-07
05060031482720Eclypse Non-BackedCR45192025-08-07
05060031484724Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031482652Eclypse Non-BackedCR45172025-08-07
05060031482690Eclypse Non-BackedCR45182025-08-07
05060031482737Eclypse Non-BackedCR45192025-08-07
05060031484748Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031485349Activon Manuka Honey Barrier CreamCR45522025-08-07
05060031482607Eclypse Non-BackedCR45162025-08-05
05060031474145Activon TulleCR41362023-07-27
05060031474107Activon TulleCR41352024-01-18
05060031479676Eclypse ContourCR43982023-07-27
05060031471182Activon TubeCR38302023-07-27
05060031482003Activon TubeCR44932023-07-27
05060031475708Advazorb Border CR41952024-01-17
05060031475715Advazorb Border CR41952024-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827104Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828149Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828156Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828163Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206828170Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
10885632506000HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29