FDA.reportPublic FDA data

NS10718 Skin Marker; Round Pen Regular Tip; w/ Ruler

Primary DI
20787551008924
Brand
NS10718 Skin Marker; Round Pen Regular Tip; w/ Ruler
Company
XODUS MEDICAL, INC.
Model
NS10718
Catalog number
NS10718
Device description
NS10718 Skin Marker; Round Pen Regular Tip; w/ Ruler
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
20787551008924PackageGS1400In Commercial Distribution
00787551008920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100892420787551008924
00787551008920007875510089207875510089200787551008920

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

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
20787551041389LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
20787551041396LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
2078755104010830250 Pink Pad - Loop Strap 29"30250302502025-07-16
20787551041228SPK10488 Jackson KitSPK10488SPK104882025-07-16
20787551041235PBK10008 Pegboard KitPBK10008PBK100082025-07-16
20787551041242SPK11661 Wilson Frame Positioning KitSPK11661SPK116612025-07-16
20787551041259SPK11649 Jackson Table Positioning KitSPK11649SPK116492025-07-16
20787551041266SPK11186 Surgical BackPack KitSPK11186SPK111862025-07-16
20787551041273NSCL25306 Custom Med Label PackNSCL25306NSCL253062025-07-16
20787551041280CL25257 Custom Med Label PackCL25257CL252572025-07-16
2078755103973740684 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Large DermaP40684406842025-04-16
20787551041082SPK11602 ProAxis Table KitSPK11602SPK116022025-04-16
20787551041105NSCL25293 Custom Med Label PackNSCL25293NSCL252932025-04-16
20787551041112NSCL25294 Custom Med Label PackNSCL25294NSCL252942025-04-16
2078755104112940688 XL Advanced Trendelenburg Positioning Kit - Biodegradable40688406882025-04-16
20787551041136SPK11632 Jackson KitSPK11632SPK116322025-04-16
20787551041143CL25296 Custom Med Label PackCL25296CL252962025-04-16
20787551041150SPK11639 Wilson Table KitSPK11639SPK116392025-04-16
20787551041167SPK11638 Jackson Table KitSPK11638SPK116382025-04-16
20787551041174SPK11640 Surgical BackPack KitSPK11640SPK116402025-04-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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G2231523360Medetz Surgical InstrumentsMedetz Surgical Instruments LLCFZZ2025-06-30
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