FDA.reportPublic FDA data

Endure

Primary DI
00840118601184
Brand
Endure
Company
ENDURE INDUSTRIES
Model
SB21A3-0520
Catalog number
SB21A3
Device description
Surgical Tape, Breathable, 2" x 10 yd
Published
2021-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00840118601184PackageGS16In Commercial Distribution
00840118601191PackageGS112In Commercial Distribution
00840118601177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118601184008401186011848401186011840840118601184
00840118601191008401186011918401186011910840118601191
00840118601177008401186011778401186011770840118601177

GMDN Terms#

Term, Definition table
TermDefinition
Hypoallergenic skin adhesive tapeA flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Yard
Width2Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6072994971Support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31
00840118603850EndureSLL50A3-0520SLL50A32020-08-31
00840118603881EndureSLS1A3-0520SLS1A32020-09-15
00840118603911EndureSLS2A3-0520SLS2A32020-09-15
00840118603942EndureSLS3A3-0520SLS3A32020-09-15
00840118603973EndureSLS5A3-0520SLS5A32020-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00861092002644Cealogic FilmRECIBIO, INC.KGX2026-03-01
50192253049815TelfaCardinal Health 200, LLCKGX2026-02-25
50192253050088TelfaCardinal Health 200, LLCKGX2026-02-25
30197344181654CURADMEDLINE INDUSTRIES, INC.KGX2026-02-23
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