FDA.reportPublic FDA data

Marking Pen

Primary DI
00841668114384
Brand
Marking Pen
Company
KATENA PRODUCTS, INC.
Model
K20-4502
Catalog number
K20-4502
Device description
MARKING PEN MICRO (PK/10)
Published
2020-09-14
Public version status
Update
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
00841668114384PrimaryGS10
00841668125441Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668114384008416681143848416681143840841668114384
00841668125441008416681254418416681254410841668125441

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
085668598
Device count
10
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

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
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
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30809160003132Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160019556Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
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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