FDA.reportPublic FDA data

Propper Duo-Spore Biological Indicator Growth Media Vials

Primary DI
10818087012307
Brand
Propper Duo-Spore Biological Indicator Growth Media Vials
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
26910700
Catalog number
26910700
Device description
Propper Duo-Spore Biological Indicator Growth Media Vials (25/bx)
Published
2020-03-04
Public version status
New
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
30818087012301PrimaryGS10
10818087012307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081808701230130818087012301
1081808701230710818087012307

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
25
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
30818087011960Propper Gas-Chex Indicator Strips26900100269001002017-10-04
70818087011623Macintosh #1 Disposable Laryngoscope Blade19924100199241002026-05-15
70818087011630Macintosh #2 Disposable Laryngoscope Blade19924200199242002026-05-15
70818087011647Macintosh #3 Disposable Laryngoscope Blade19924300199243002026-05-15
70818087011814Macintosh #4 Disposable Laryngoscope Blade19924400199244002026-05-15
70818087011821Miller #0 Disposable Laryngoscope Blade19934000199340002026-05-15
70818087012040Miller #2 Disposable Laryngoscope Blade19934200199342002026-05-15
70818087012156Miller #3 Disposable Laryngoscope Blade19934300199343002026-05-15
70818087012163Miller #4 Disposable Laryngoscope Blade19934400199344002026-05-15
70818087013214Miller #1 Disposable Laryngoscope Blade19934100199341002026-05-15
30818087010918"Verline Steam Autoclave Indicator Tape 1/2"" x 14 YD - 24/pack"26814400268144002023-06-16
30818087010932"Verline Steam Autoclave Indicator Tape 3/4"" x 14 YD - 16/pack"26814500268145002023-06-16
30818087010949"Verline Steam Autoclave Indicator Tape 1"" x 14 YD - 12/pack"26814600268146002023-06-16
30818087012271"Propper 9/16"" Steri-Dot Process Indicator"36100100361001002021-09-12
30818087012325"Propper 1"" Steri-Dot Process Indicator"36100200361002002021-09-12
30818087012400"Propper 3/4"" Steam Dot Process Indicator"36400100364001002021-09-12
70818087010343"Propper Verline Indicator Tape 1/2"" x 14 YDS"26824416268244162022-10-20
70818087010367"Propper 3/4"" Steri-Dot Process Indicator Bulk Pack (110 RL/CS)"36100801361008012022-10-28
70818087010732"Propper Verline 1/2"" Steam Autoclave Tape Mini-Rolls"26814416268144162023-02-23
70818087010749"Propper Verline 3/4"" Steam Autoclave Tape Mini-Rolls"26814516268145162023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
107073878129323M™ Attest™3M COMPANYFRC2026-04-26
107073878129563M™ Attest™3M COMPANYFRC2026-04-26
307073875085563M™ Attest™3M COMPANYFRC2026-04-26
107073878151173M™ Attest™3M COMPANYFRC2026-04-10
107073878151243M™ Attest™3M COMPANYFRC2026-04-10
307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
07798375773607BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037071319ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164670070Bionova®TERRAGENE S.A.FRC2025-10-16
07798164670209Bionova®TERRAGENE S.A.FRC2025-10-16
07798164673545Bionova®TERRAGENE S.A.FRC2025-10-16
07798375773539ProEdgeTERRAGENE S.A.FRC2025-10-16
10686864061257AssureCheck™TERRAGENE S.A.FRC2025-10-16
07798375773034BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161001Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C1Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772983BIOTRACE™TERRAGENE S.A.FRC2024-11-12
10686864060892Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14