FDA.report

NS10717 Skin Marker; Round Pen Regular Tip; w/ Ruler and Labels

Primary DI
20787551008917
Brand
NS10717 Skin Marker; Round Pen Regular Tip; w/ Ruler and Labels
Company
XODUS MEDICAL, INC.
Model
NS10717
Catalog number
NS10717
Device description
NS10717 Skin Marker; Round Pen Regular Tip; w/ Ruler and Labels
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

Related Records

Contact Domains

Product Codes

CodeName
FZZMARKER, SKIN

Product Code Classifications

CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20787551008917PackageGS1400In Commercial Distribution
00787551008913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100891720787551008917
00787551008913007875510089137875510089130787551008913

GMDN Terms

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

Contacts

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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