FDA.report

Propper Duo Spore Biological Indicators

Primary DI
30818087012202
Brand
Propper Duo Spore Biological Indicators
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
26909200
Catalog number
26909200
Device description
Duo Spore® Biological Indicator Test w/ Culture Service - Steam or Ethylene Oxide - 1 test envelope
Published
2017-10-17
Public version status
Update
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

Product Codes

CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications

CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30818087012202PrimaryGS10
10818087012208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3081808701220230818087012202
1081808701220810818087012208

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

Regulatory Flags

DUNS number
001483130
Device count
3
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
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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