FDA.reportPublic FDA data

Mckesson

Primary DI
00612479259058
Brand
Mckesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
19-0762
Device description
Marker, skin, fine tip, w/ ruler/labels
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479259058PackageGS150In Commercial Distribution
00612479259041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479259058006124792590586124792590580612479259058
00612479259041006124792590416124792590410612479259041

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

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G42520103680My MedicalMy Medical Store LLCFZZ2026-02-26
G42520104020My MedicalMy Medical Store LLCFZZ2026-02-26
26931918101047AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918108411AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918152353AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918161324AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918172931AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
07540277010041RMAC SurgicalRMAC Surgical, IncFZZ2026-01-06
00860012465019FungalBlueToeFX IncFZZ2025-12-03
00194613019075MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613020842MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613022754MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613043643MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613046187MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613057039MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613088286MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094058MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094065MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094072MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613107116MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613108496MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613121020MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123260MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123277MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123291MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
G2231523360Medetz Surgical InstrumentsMedetz Surgical Instruments LLCFZZ2025-06-30
10714646001129Sample: Opti-TattBionix, LLCFZZ2025-06-20
40080196771852MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389025940MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389711799MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12