FDA.reportPublic FDA data

Cramer

Primary DI
00311960751902
Brand
Cramer
Company
HYGENIC CORPORATION, THE
Model
762969
Device description
Self Stick Stretch Athletic Tape blister, Black 3” x 5yd
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
20311960751906PackageGS11In Commercial Distribution
80311960751908PackageGS11In Commercial Distribution
00311960751902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2031196075190620311960751906
8031196075190880311960751908
00311960751902003119607519023119607519020311960751902

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Yard
Width2Inch

Regulatory Flags#

DUNS number
004163390
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087453001662Hygenic155832026-01-13
00087453001679Hygenic155842026-01-13
00087453127560TheraBand Kinesiology Tape127562025-03-11
00087453127577TheraBand Kinesiology Tape127572025-03-11
00087453127584TheraBand Kinesiology Tape127582025-03-11
00087453143478Hysynal143472025-03-10
00087453127409TheraBand Kinesiology Tape127402025-03-10
00087453127447TheraBand Kinesiology Tape127442025-03-10
00087453127454TheraBand Kinesiology Tape127452025-03-10
00087453127461TheraBand Kinesiology Tape127462025-03-10
00087453127478TheraBand Kinesiology Tape127472025-03-10
00087453127492TheraBand Kinesiology Tape127492025-03-10
20087453143472Hysynal143472025-03-10
00087453127393TheraBand Kinesiology Tape127392025-03-10
00087453127416TheraBand Kinesiology Tape127412025-03-10
00087453102048Hysynal102042019-04-08
00087453127515TheraBand Kinesiology Tape 127512019-02-08
00087453127522TheraBand Kinesiology Tape 127522019-02-08
00087453127539TheraBand Kinesiology Tape 127532019-02-08
00087453127546TheraBand Kinesiology Tape 127542019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
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
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