FDA.reportPublic FDA data

NS10737 Dual Tip Marker; Regular Tip Gentian Violet and Permanent Ink; w/Ruler

Primary DI
20787551009129
Brand
NS10737 Dual Tip Marker; Regular Tip Gentian Violet and Permanent Ink; w/Ruler
Company
XODUS MEDICAL, INC.
Model
NS10737
Catalog number
NS10737
Device description
NS10737 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink; w/ Ruler
Published
2022-12-13
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
20787551009129PackageGS1400In Commercial Distribution
00787551009125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100912920787551009129
00787551009125007875510091257875510091250787551009125

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

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00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
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0078755104160640674 Hot Pink Pad EXT40674406742026-04-30
00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
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00787551041392LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
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