FDA.report

SporView™ 10 Self-Contained Biological Indicator

Primary DI
00732224723280
Brand
SporView™ 10 Self-Contained Biological Indicator
Company
CROSSTEX INTERNATIONAL, INC.
Model
SVT-056
Device description
10 Hour Steam Self-contained Biological Indicator
Published
2020-03-31
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
FRCIndicator, biological sterilization process

Product Code Classifications

CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10732224723287PrimaryGS10
00732224723280Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222472328710732224723287
00732224723280007322247232807322247232800732224723280

GMDN Terms

TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(585)359-0130info@spsmedical.com

Regulatory Flags

DUNS number
057728685
Device count
50
DM exempt
true
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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