FDA.reportPublic FDA data

Silkafix

Primary DI
04021447022284
Brand
Silkafix
Company
Lohmann & Rauscher International GmbH & Co KG
Model
Adhesive tape 2,5cm x 5m
Catalog number
34325
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04021447022291PackageGS128In Commercial Distribution
04021447343259PackageGS112In Commercial Distribution
04021447022284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04021447022291040214470222914021447022291
04021447343259040214473432594021447343259
04021447022284040214470222844021447022284

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry

Regulatory Flags#

DUNS number
315505235
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
04021447165158Pro-ophta@Ocular Sticks165152016-10-17
04021447537771DebrisoftPad 10x10cm312222022-11-17
04056649025665DebrisoftLolly332242023-06-07
04056649070344DebrisoftPad 10x10cm343212022-11-17
04056649070429DebrisoftPad 13x20cm343232022-11-17
04068225259449DebrisoftDuo 10x10cm1599902024-10-16
04068225259463DebrisoftDuo 13x20cm1599912024-10-16
04068225269608DebrisoftDuo 10x10cm1599922024-10-16
04068225274879DebrisoftDuo 10x10cm312222024-10-16
04021447206028VaricexZinc Paste Bandage206022022-11-17
04021447206325VaricexZinc Paste Bandage206322022-11-17
04068225066924SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066955SuprasorbF Protect 5 x 7 cm1624612024-11-15
04068225066986SuprasorbF Protect 10 cm x 12 cm1624622024-11-15
04068225067013SuprasorbF Protect 10 cm x 12 cm1624632024-11-15
04068225067044SuprasorbF Protect 10 cm x 25 cm1624642024-11-15
04068225067075SuprasorbF Protect 15 cm x 20 cm1624652024-11-15
04068225067105SuprasorbF Protect 20 x 30 cm1624662024-11-15
04068225066931SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066962SuprasorbF Protect 5 x 7 cm1624612024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
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
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07