FDA.reportPublic FDA data

Endure

Primary DI
00840118601658
Brand
Endure
Company
ENDURE INDUSTRIES
Model
SH31A3-0520
Catalog number
SH31A3
Device description
"Surgical Tape, High Strength, Bi-Directional Tear, 3"" x 10 yd"
Published
2020-09-29
Public version status
Update
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
00840118601665PackageGS112In Commercial Distribution
00840118601672PackageGS14In Commercial Distribution
00840118601658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118601665008401186016658401186016650840118601665
00840118601672008401186016728401186016720840118601672
00840118601658008401186016588401186016580840118601658

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical skin adhesive tapeA long thin band of synthetic material coated on one or both sides with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or a combination of materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Yard
Width3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6072994971Support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118621137Endure IndustriesOMEP11OMEP112026-08-17
00840118600361Endure IndustriesNDAFC211NDAFC2112026-08-14
00840118602150Endure IndustriesECAKCDQ-118ECAKCDQ-1182026-08-14
00840118607988Endure IndustriesNCAC211NCAC2112026-08-14
00840118609616Endure IndustriesNDAMC211NDAMC2112026-08-14
00840118614245Endure IndustriesESP38ESP382026-08-14
00840118614252Endure IndustriesESP310ESP3102026-08-14
00840118614269Endure IndustriesESP511ESP5112026-08-14
00840118614276Endure IndustriesESP516ESP5162026-08-14
00840118614283Endure IndustriesESP713ESP7132026-08-14
00840118614290Endure IndustriesESP916ESP9162026-08-14
00840118614306Endure IndustriesESP1118ESP11182026-08-14
00840118614900Endure IndustriesNDAF211NDAF2112026-08-14
00840118616447Endure IndustriesEBSEBS2026-08-14
00840118617338Endure IndustriesNDAM411UNDAM411U2026-08-14
00840118617352Endure IndustriesNDAM411NDAM4112026-08-14
00840118617376Endure IndustriesNDAF411UNDAF411U2026-08-14
00840118617390Endure IndustriesNDAF411NDAF4112026-08-14
00840118617413Endure IndustriesNCPC211NCPC2112026-08-14
00840118617437Endure IndustriesNDPM211NDPM2112026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23