FDA.reportPublic FDA data

Medical Action Industries

Primary DI
30809160003132
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
Rx
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160523155MEDICAL ACTION INDUSTRIES850142026-06-09
10809160226100Splash Medical Devices715622019-02-05
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10

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
10809160003138Medical 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
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