FDA.report

Endure

Primary DI
00840118601092
Brand
Endure
Company
ENDURE INDUSTRIES
Model
SB15A3-0520
Catalog number
SB15A3
Device description
Surgical Tape, Breathable, 1" x 5.5 yd
Published
2020-09-29
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

Related Records

Contact Domains

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118601092PackageGS112In Commercial Distribution
00840118601108PackageGS112In Commercial Distribution
00840118601085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118601092008401186010928401186010920840118601092
00840118601108008401186011088401186011080840118601108
00840118601085008401186010858401186010850840118601085

GMDN Terms

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

TypeValueUnit
Length5.5Yard
Width1Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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00840118600507EndureSP11A3-0520SP11A32020-11-19
00840118600538EndureSP21A3-0520SP21A32020-11-19
00840118600569EndureSP22A3-0520SP22A32020-11-19
00840118600590EndureSP31A3-0520SP31A32020-11-19
00840118600620EndureSP41A3-0520SP41A32020-11-19
00840118600651EndureSP42A3-0520SP42A32020-11-19
00840118600682EndureSP61A3-0520SP61A32020-11-19
00840118600712EndureSP62A3-0520SP62A32020-11-19
00840118600743EndureSP81A3-0520SP81A32020-11-19
00840118614566ENDURE INDUSTRIESIDABA8IDABA82024-10-04
00840118614597ENDURE INDUSTRIESIDAPA8IDAPA82024-10-04
00840118617840ENDURE INDUSTRIESUB1GA9UB1GA92024-04-17
00840118617871ENDURE INDUSTRIESUB2LA9UB2LA92024-04-17
00840118606660ENDURE INDUSTRIESCBP150A8CBP150A82024-04-10
00840118606684ENDURE INDUSTRIESCB70A8CB70A82024-04-10
00840118606707ENDURE INDUSTRIESCBTA8CBTA82024-04-10
00840118608077ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118615297ENDURE INDUSTRIESGS13GS132024-04-10
00840118609722ENDURE INDUSTRIESWSS44WSS442024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10

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