FDA.report

SCANLAN® Surgical skin markers

Primary DI
00846159000368
Brand
SCANLAN® Surgical skin markers
Company
SCANLAN INTERNATIONAL INC
Model
1001-710
Catalog number
1001-710
Device description
SCANLAN® Surgical skin markers - Regular Tip, Gentian Violet (1 per sterile package with ruler)
Published
2018-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
00846159000368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159000368008461590003688461590003680846159000368

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
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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