FDA.reportPublic FDA data

Siltape

Primary DI
05060031473346
Brand
Siltape
Company
BRIGHTWAKE LIMITED
Model
CR3939
Device description
Soft Silicone Perforated Tape, 4 cm X 1.5 m. Siltape is a soft silicone fixation tape delivered on a roll with perforations for ease of use. Siltape is made from Silicone that is gentler on removal unlike other adhesives that may cause tissue damage when removed and is particularly useful in patients with very thin, friable skin.
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060031473360PackageGS112In Commercial Distribution
05060031473346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031473360050600314733605060031473360
05060031473346050600314733465060031473346

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, siliconeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Meter
Width4Centimeter

Contacts#

Phone, Email table
PhoneEmail
+441623751151sales@brightwake.co.uk

Regulatory Flags#

DUNS number
226502201
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing 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
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31