FDA.reportPublic FDA data

Skin MarkOR Fine Tip

Primary DI
09349967004036
Brand
Skin MarkOR Fine Tip
Company
THE O R COMPANY PTY LTD
Model
SMOR-F
Published
2021-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
09349967004043PackageGS136Not in Commercial Distribution
09349967004050PackageGS110Not in Commercial Distribution
09349967004036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967004043093499670040439349967004043
09349967004050093499670040509349967004050
09349967004036093499670040369349967004036

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.

Regulatory Flags#

DUNS number
744346235
Device count
1
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
09349967002759Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002780Uterine ElevatOR ProUE-TVPRO-352018-01-31
09349967002810Uterine ElevatOR ProUE-TVPRO-372018-01-31
09349967002841Uterine ElevatOR Pro UE-TVPRO-402018-01-31
09349967003268Lap Scope WarmORSW-5-10-R2019-03-27
09349967003442ColpotomizOR Tube SystemCTS35-TV2019-03-27
09349967003473ColpotomizOR Tube SystemCTS45-TV2019-03-27
09349967004067Skin MarkOR Regular TipSMOR-R2021-04-12
09349967004210Laparoscopic Smoke EvacuatorLSE-012021-04-12
09349967004968Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
09349967004975Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
09349967004982Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
09349967005019Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
09349967005064Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
09349967005071Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
09349967005088Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
09349967005095Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
09349967005101Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
19349967004972Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26

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