SchurSign

Primary DI
04262491960003
Brand
SchurSign
Company
SurgMark GmbH
Model
SchurSign 1.5-5
Device description
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
Published
2024-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230836000SchurSign Tissue MarkerSurgmark GmbH2024-01-23NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262491960010PackageGS110In Commercial Distribution
04262491960003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262491960010042624919600104262491960010
04262491960003042624919600034262491960003

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4996433007404info@surgmark.com

Regulatory Flags#

DUNS number
314521564
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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