RIVERPOINT BRACHYTHERAPY

Primary DI
00812444022124
Brand
RIVERPOINT BRACHYTHERAPY
Company
RIVERPOINT MEDICAL, LLC
Model
GM1053-1820
Device description
BRACHYHERAPY
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K103449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103449000BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERSRiverpoint Medical2011-02-25KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812444022121PackageGS15In Commercial Distribution
20812444022128PackageGS19In Commercial Distribution
30812444022125PackageGS110In Commercial Distribution
00812444022124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081244402212110812444022121
2081244402212820812444022128
3081244402212530812444022125
00812444022124008124440221248124440221240812444022124

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.

Regulatory Flags#

DUNS number
964053560
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022162RIVERPOINT BRACHYTHERAPYGM1233-17202015-10-22
00812444022216RIVERPOINT BRACHYTHERAPYGM1253-17202015-10-22
00812444022223GOLD MARKER NEEDLEGM1251-17202015-10-23
00812444022230GOLD MARKER NEEDLEGM0833-18202015-10-24
00812444022919RIVERPOINT BRACHYTHERAPYGM0853-18202015-10-24
00812444023183RIVERPOINT BRACHYTHERAPYGM0833K-18202015-10-22
00812444023237FIDUCIAL NEEDLESFN17-532015-10-24
00812444023244FIDUCIAL NEEDLESFN17-312015-10-24
00812444023299FIDUCIAL NEEDLESFN18-12015-10-24
00812444023305FIDUCIAL NEEDLESFN17-32015-10-24
00812444023312FIDUCIAL NEEDLESFN18-32015-10-24
00812444023411RIVERPOINT BRACHYTHERAPYGM0851-18202015-10-24
00812444023428RIVERPOINT BRACHYTHERAPYGM0851K-18202015-10-24
00812444023435RIVERPOINT BRACHYTHERAPYGM0831K-18202015-10-24
00812444023442RIVERPOINT BRACHYTHERAPYGM0853K-18202015-10-24
00812444023466RIVERPOINT BRACHYTHERAPYGM0851-SS25-18202015-10-24
00812444023473RIVERPOINT BRACHYTHERAPYGM0451-20202015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
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07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
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