FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160002544
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
4010
Published
2016-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003002000STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123Steritec Products, Inc.2000-12-08JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160002541PackageGS148Not in Commercial Distribution
10809160002544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916000254120809160002541
1080916000254410809160002544

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00KEEP DRY; KEEP AWAY FROM DIREC

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160538913HalyardMHSH2002-012026-09-24
10809160541029Medical Action IndustriesDNAG082026-10-21
10809160541036Medical Action IndustriesDNPP092026-10-21
10809160541043Medical Action IndustriesDNSP112026-10-21
10809160541050Medical Action IndustriesDNUR812026-10-21
10809160541067Medical Action IndustriesDNVP972026-10-21
10809160540879MEDICAL ACTION INDUSTRIES79143C2026-10-20
10809160540626HalyardLLOF2700-022026-10-14
10809160540473Medical Action IndustriesLH_851772026-10-12
10809160540480HalyardSHAN454-052026-10-12
10809160540107Medical Action IndustriesLMHA01-012026-10-08
10809160183472Medical Action Industries773452018-03-22
10809160536803HalyardHVMC003-042026-09-18
10809160539965Medical Action Industries845252026-10-06
10809160539125HalyardLLOF021-012026-09-30
10809160539019Medical Action Industries83989B2026-09-25
10809160539026HalyardDNAZ037-032026-09-25
10809160535523HalyardLLOF3100-022026-09-24
10809160538937HalyardAXOG2000-122026-09-24
10809160538968HalyardDNAZ034-032026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362973VERIFYALBERT BROWNE LIMITEDJOJ2026-07-16
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00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
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00840456202999JMUJMU DENTAL, INCJOJ2026-06-05