FDA.reportPublic FDA data

True Indicating Sterilization Indicator Tape

Primary DI
00860011103424
Brand
True Indicating Sterilization Indicator Tape
Company
True Indicating LLC
Model
CSWN-1T
Device description
The Sterilization indicator tape is designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off-yellow to Dark brown/Black. Use the Sterilization indicator tape in steam sterilization processes described below. 1. 121°C, 30 minutes; Gravity Steam 2. 132°C, 4 minutes; Dynamic Air Removal Steam 3. 135°C, 3 minutes; Dynamic Air Removal Steam
Published
2025-03-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011103424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011103424008600111034248600111034240860011103424

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 (non-electrical) 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116935598
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011103486True IndicatingMSCST-05-252024-04-05
00850064244045LarrCSPN-15L2025-04-02
00850064244052CheetaCHE-CSPN-15G2025-04-02
00850064244038True IndicatingCSPN-152025-02-27
00860008246707Instant 20s IndicatorISCS-05ISCS-052023-05-12
00197644183036Excelsior ScientificISCS-05EISCS-05E2023-05-12
00850064244007True IndicatingMSCST-05MSCST-052024-05-01
00860011103493Larr-Test 24MSCST-05LMSCST-05L2024-04-29
00860011103400Larr-Test 24MSCST-05LMSCST-05L2023-11-02
00197644080601SterimSRI-050SRI-0502023-04-28
00197644533428SterimSBI-100SBI-1002023-04-28
00860008246714True IndicatingMSCST-05MSCST-052023-04-28
00860008246738Excelsior ScientificMSCS-05EMSCS-05E2023-04-28
00860008246745Larr-Test 24MSCST-05LMSCST-05L2023-04-28
00860008246769ApprovedMSCST-05SFMSCST-05SF2023-04-28

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Primary DI, Brand, Company table
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