FDA.reportPublic FDA data

DISPOSABLE REGULAR MARKING PENS 10/BOX

Primary DI
00841668142974
Brand
DISPOSABLE REGULAR MARKING PENS 10/BOX
Company
KATENA PRODUCTS, INC.
Model
AS-1583N
Catalog number
AS-1583N
Device description
DISPOSABLE REGULAR MARKING PENS 10/BOX
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00841668142974PrimaryGS10
10841668142971Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668142974008416681429748416681429740841668142974
1084166814297110841668142971

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.

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
10
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540277010041RMAC SurgicalRMAC Surgical, IncHRP2026-01-06
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
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