FDA.reportPublic FDA data

Propper Duo Spore Biological Indicators

Primary DI
30818087012219
Brand
Propper Duo Spore Biological Indicators
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
26909300
Catalog number
26909300
Device description
Duo Spore® Biological Indicator Test w/ Culture Service - Steam or Ethylene Oxide - 4 test envelopes
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

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818087012219PrimaryGS10
10818087012215Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081808701221930818087012219
1081808701221510818087012215

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
001483130
Device count
12
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818087011072EO Chex 3/4" Indicator Tape - 48 rolls/case26811500268115002024-07-26
10818087011089EO Chex 1" Indicator Tape - 36 rolls/case26811600268116002024-07-26
10818087010815Seraket Tourniquets22700000227000002023-06-16
10818087010952Gas-Chex EO Gas 3/4" Indicator Tape26822500268225002023-06-16
10818087010914Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack26814400268144002023-06-16
10818087010938Verline Steam Autoclave Indicator Tape 3/4" x 14 YD - 16/pack26814500268145002023-06-16
10818087010945Verline Steam Autoclave Indicator Tape 1" x 14 YD - 12/pack26814600268146002023-06-16
30818087010994Vapor Line Reusable Process Challenge Device26906900269069002023-06-16
10818087011003BI-OK Ethylene Oxide Gas Vials26930100269301002023-06-16
10818087010822Seraket Tourniquets22712000227120002023-06-16
10818087011669Seraket Tourniquets22700100227001002023-06-16
10818087010785Anaerobe Systems Sterilization Pouches02501800025018002023-04-18
10818087010730Propper Verline 1/2" Steam Autoclave Tape Mini-Rolls26814416268144162023-02-23
10818087010747Propper Verline 3/4" Steam Autoclave Tape Mini-Rolls26814516268145162023-02-23
10818087010754Propper Verline 1" Steam Autoclave Tape Mini-Rolls26814616268146162023-02-23
10818087012710Propper Steri-Wrap III 54"x54"31305400313054002022-12-04
10818087010365Propper 3/4" Steri-Dot Process Indicator Bulk Pack (110 RL/CS)36100801361008012022-10-28
10818087010341Propper Verline Indicator Tape 1/2" x 14 YDS26824416268244162022-10-20
30818087012172Propper Verline Indicator Tape 1" x 14 YDS26824616268246162022-10-19
10818087012192Propper Verline Indicator Tape 3/4" x 14 YDS26824516268245162022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07798375773591BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037066674STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066681STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066698STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066704STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066711STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037070718ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164677970Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678069Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678083Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678090Bionova®TERRAGENE S.A.FRC2025-08-01
00850065007489SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
00850065007496SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
07798164674948Bionova®TERRAGENE S.A.FRC2025-04-25
07798164679103Bionova®TERRAGENE S.A.FRC2025-03-06
07798375772495BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375772501BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375773041BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161000Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C0Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T0Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY1201017960 HealthFirst Mail-In Spore Testing Service, 12 TestMESA LABORATORIES, INC.FRC2024-12-18
07798375772877BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375773003BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772990BIOTRACE™TERRAGENE S.A.FRC2024-11-12
00686864060895Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14