VeraForm

Primary DI
00850016008039
Brand
VeraForm
Company
Viscus Biologics LLC
Model
60023
Catalog number
60023
Device description
VeraForm Adaptable Tissue Marker
Published
2021-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190155000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190155000FibermarX Radiopaque Tissue MarkerViscus Biologics, LLC2019-02-27IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016008046PackageGS15In Commercial Distribution
00850016008053PackageGS110In Commercial Distribution
00850016008039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016008046008500160080468500160080460850016008046
00850016008053008500160080538500160080530850016008053
00850016008039008500160080398500160080390850016008039

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Contacts#

Phone, Email table
PhoneEmail
415-706-5798customersupport@viderasurgical.com

Regulatory Flags#

DUNS number
031183936
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016008190BaseMEM60088600882026-09-21
00850016008206BaseMEM60089600892026-09-21
00850016008220BaseMEM60090600902026-09-21
00850016008176VeraForm60023600232024-01-16
00850016008008FibermarX60004600042018-01-18
00850016008183VeraForm60023600232024-01-16
00850016008046VeraForm01500242021-06-23

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