FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160003138
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
115BR
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRPPEN, MARKING, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRPPen, Marking, SurgicalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160003135PackageGS125Not in Commercial Distribution
30809160003132PackageGS14Not in Commercial Distribution
10809160003138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916000313520809160003135
3080916000313230809160003132
1080916000313810809160003138

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00store at room temperature

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160536506HalyardLLOG1000-182026-09-18
10809160536544HalyardSHSD015-042026-09-18
10809160536612HalyardWBAM068-042026-09-18
10809160536629HalyardSLAK19-042026-09-18
10809160536667HalyardSWDS001-022026-09-18
10809160536674HalyardLOUS019-162026-09-18
10809160536681HalyardLCNW001-122026-09-18
10809160536728HalyardSHAN453-052026-09-18
10809160536735HalyardLCNW002-032026-09-18
10809160536742HalyardFLDR004-022026-09-18
10809160536759HalyardLIFE0070-082026-09-18
10809160536766HalyardLOUS018-022026-09-18
10809160536773HalyardRDLD033-062026-09-18
10809160536797HalyardMSMT46-062026-09-18
10809160536803HalyardHVMC003-042026-09-18
10809160536810HalyardKRIV26-032026-09-18
10809160536827HalyardMETC002-042026-09-18
10809160536834HalyardLAKC032-022026-09-18
10809160536841HalyardRDLD039-102026-09-18
10809160536858HalyardONEL038-022026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540277010041RMAC SurgicalRMAC Surgical, IncHRP2026-01-06
00841668142974DISPOSABLE REGULAR MARKING PENS 10/BOXKATENA PRODUCTS, INC.HRP2022-12-13
00841668142981DISPOSABLE MICRO MARKING PENS 10/BOXKATENA PRODUCTS, INC.HRP2022-12-13
00841668114360Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668114377Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668114384Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668113219Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125427Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125434Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125441Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
10809160002803Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002810Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002827Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002834Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003121Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003145Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003152Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003237Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003244Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003251Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160004449Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
30809160003132Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160019556Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160019563Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022075Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022082Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022099Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022105Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022112Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20