FDA.reportPublic FDA data

Axion

Primary DI
04260280185507
Brand
Axion
Company
Axion USA LLC
Model
328010
Device description
The STIM-PRO FlexTape is an elastic adhesive tape, with a strong fabric structure for heavier load. The product is made of cotton, spandex and hot-melt adhesive with zinc oxide. It is water-repellent and has a high wearing comfort due to the viscose material. With an elasticity of 40-60%, it is very flexible and adaptable.STIM-PRO FlexTape is used supportively to protect the human musculoskeletal system from injury or to relieve pain caused by strains, overstretching and/or swelling
Published
2023-09-05
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
04260280185507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260280185507042602801855074260280185507

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124912022
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260280181929Axion201272025-04-09
04260280181318Axion10232024-05-11
04260280180335Axion200642024-03-18
04260280180533Axion200152023-12-01
04260280181875Axion201222023-12-01
04260280183510Axion202222023-12-01
04260280182063Axion201392023-11-23
04260280182070Axion201402023-11-22
04260280185521Axion3280082023-10-26
04260280185538Axion3280072023-10-26
04260280184128Axion3270062023-09-08
04260280185255Axion3270102023-09-08
04260280180793Axion200272023-09-07
04260280180830Axion200352023-09-07
04260280180960Axion200452023-09-05
04260280181349Axion201142023-09-05
04260280180366Axion200632023-09-01
04260280182889Axion200622023-09-01
04260280184104Axion3270042023-09-01
04260280185491Axion3280062023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346726660EquateWAL-MART STORES, INC.KGX2026-10-22
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25