VeraForm

Primary DI
00850016008183
Brand
VeraForm
Company
Viscus Biologics LLC
Model
60023
Catalog number
60023
Device description
VeraForm Adaptable Tissue Marker
Published
2024-01-16
Public version status
New
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
00850016008183PackageGS15In Commercial Distribution
10850016008180PackageGS110In Commercial Distribution
00850016008176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016008183008500160081838500160081830850016008183
1085001600818010850016008180
00850016008176008500160081768500160081760850016008176

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
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
00850016008039VeraForm60023600232021-06-23
00850016008176VeraForm60023600232024-01-16
00850016008008FibermarX60004600042018-01-18
00850016008046VeraForm01500242021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700582Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700643Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700667Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701060Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701084Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701107Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701121Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701145Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701183Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701206Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
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