FDA.report

EchoMark

Primary DI
B53630001
Brand
EchoMark
Company
SONAVEX, INC.
Model
3000
Device description
EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
Published
2018-12-06
Public version status
New
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
NEUMarker, Radiographic, Implantable

Product Code Classifications

CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K180621000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K180621000EchoMark, EchoMark LPSonavex, Inc.2018-06-06NEU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B53630001PrimaryHIBCC0

GMDN Terms

TermDefinition
Imaging lesion localization marker, implantableA sterile 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 formed as a wire, needle, bead, stent-like tube or washer, 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(443)862-2024contact@sonavex.com

Regulatory Flags

DUNS number
079208177
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B53620001EchoMark LP20002018-12-06

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