FDA.reportPublic FDA data

N'Sure Indicator Tape

Primary DI
D724J0800101
Brand
N'Sure Indicator Tape
Company
PEARSON DENTAL SUPPLIES, INC.
Model
J080010
Device description
"1"""
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D724J0800101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082874108
Device count
1
Kit
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D724H6503001Vivid TruEtch 40% H65-03002018-05-09
D724H6503021Vivid TruEtch 40% H65-03022018-05-09
D724H6503041Vivid TruEtch 40% UnisyringeH65-03042018-05-09
D724H6503061Vivid TruEtch 40% Jumbo syringeH65-03062018-05-09
D724H6503081Vivid TruEtch 40% Jumbo syringeH65-03082018-05-09
D724H6503101Vivid TruEtch 10% Kit H65-03102018-05-09
D724Z0603121Vivid Etch 40%z0603122016-06-29
D724Z0603141Vivid Etch 40%Z0603142016-06-29
D724Z0603160Vivid Etch 40%Z0603162016-06-29
D724Z0603180Vivid Etch 40% refillZ0603182016-06-29
D724Z0603200VividEtch 40% Jumbo 60gm RefillZ0603202016-07-07
D724Z0603241Vivid Etch 10%z0603242016-06-29
D724D4407260Vivid TempFill LCD4407462016-06-28
D724S2702701Vivid Root MTA S2702702016-06-30
D724J0800061N'Sure Indicator TapeJ0800062016-07-26
D724J0800081N'Sure Indicator TapeJ0800082016-07-26
D724D0104501Vivid Surebond VIID0104502016-06-21
D724D0104521Vivid Surebond VII RefillD0104522016-06-21
D724S2702601Vivid Ceramic PrimeS2702602016-06-30
D724B0105080Vivid Electrode Tip #11B8805082016-06-20