FDA.report

NA

Primary DI
00724995221973
Brand
NA
Company
STERIS CORPORATION
Model
260010
Catalog number
260010
Device description
The VERIFY STEAM Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing and its color-changing indicator stripes provides immediate identification that items were exposed to a steam cycle.
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10724995184916PreviousGS10
10724995221970PrimaryGS10
00724995221973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518491610724995184916
1072499522197010724995221970
00724995221973007249952219737249952219730724995221973

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length60Yard
Width1Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Controlled Room Temperature
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
868205779
Device count
9
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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