FDA.reportPublic FDA data

Tensoplast®

Primary DI
04042809005554
Brand
Tensoplast®
Company
BSN MEDICAL SAS
Model
02126-00
Catalog number
02126-00
Device description
"TENSOPLAST BANDAGE 6"" X 5YDS WHITE 12"
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
04042809005554PrimaryGS10
04042809005530Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809005554040428090055544042809005554
04042809005530040428090055304042809005530

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-useA strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length450Centimeter
Width15Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags#

DUNS number
397500849
Device count
12
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042809005431Tensoplast®02114-0002114-002022-12-08
04042809005462Tensoplast®02115-0002115-002022-12-08
04042809005493Tensoplast®02117-0002117-002022-12-08
04042809005561Tensoplast®02139-002022-12-08
04042809005592Tensoplast®02144-002022-12-08
04042809005622Tensoplast®02148-002022-12-08
04042809005653Tensoplast®02153-002022-12-08
04042809005684Tensoplast®02174-002022-12-08
04042809005769Tensoplast®02155-0002155-002022-12-08
04042809005790Tensoplast®02167-002022-12-08
04042809005820Tensoplast®02168-0002168-002022-12-08
04042809006063Tensoplast®02119-0002119-002022-12-08
04042809006100Tensoplast®02154-002022-12-08
04042809009781Lightplast®76952-0076952-002022-12-08
04042809009798Lightplast®76953-002022-12-08
04042809009828Lightplast®76954-002022-12-08
04042809009859Lightplast®76955-002022-12-08
04042809009880Lightplast®76956-002022-12-08
04042809009910Lightplast®76957-002022-12-08
04042809120028Lightplast®72880-0072880-002022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22