FDA.reportPublic FDA data

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
00840277407962JuggerKnotless® Soft Anchor1200039652025-10-13
00840277407979JuggerKnotless® Soft Anchor1200039662025-10-13
00840277407986JuggerKnotless® Soft Anchor1200039672025-10-13
00840277407993JuggerLoop™ Soft Anchor1200039682025-10-13
00840277408006JuggerLoop™ Soft Anchor1200039692025-10-13
00840277408013JuggerLoop™ Soft Anchor1200039702025-10-13
00840277408020JuggerLoop™ Soft Anchor1200039712025-10-13
00840277407955JuggerKnotless Soft Anchor1200039642025-07-29
00840277405012OC JuggerKnotless® Soft Anchor1200039562024-12-19
00840277405029OC JuggerKnotless® Soft Anchor1200039572024-12-19
00840277405036OC JuggerKnotless® Soft Anchor1200039582024-12-19
00840277405043OC JuggerKnotless® Soft Anchor1200039592024-12-19
00840277405050OC JuggerLoop™ Soft Anchor1200039602024-12-19
00840277405067OC JuggerLoop™ Soft Anchor1200039612024-12-19
00840277405074OC JuggerLoop™ Soft Anchor1200039622024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SP1200039632024-12-19
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022162RIVERPOINT BRACHYTHERAPYGM1233-17202015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
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00850065937250eMotusEMPNIA INC.IYE2026-09-21