FDA.reportPublic FDA data

McKesson

Primary DI
20612479159185
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
73-SBT025
Device description
TEST PACK, STM BI W/25 CONTROL
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
40612479159196PackageGS125In Commercial Distribution
20612479159185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247915919640612479159196
2061247915918520612479159185

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
023904428
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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