FDA.reportPublic FDA data

RELI

Primary DI
00386120008592
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
R-MRN2111
Catalog number
R-MRN2111
Device description
MAMMOREP N® Breast localization needle, simple hook-wire 21G x 11cm
Published
2018-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051506000MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSYSterylab S.R.L.2005-07-27FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386120008599PackageGS125In Commercial Distribution
00386120008592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612000859910386120008599
00386120008592003861200085923861200085920386120008592

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Centimeter
Needle Gauge21Gauge

Regulatory Flags#

DUNS number
879187821
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386120015088RELI®SST-35W2026-10-01
00386120005669RELIPT7773-SI2015-10-24
00386120006314RELIPT1001-SI2016-04-15
00386120006321RELIPT1002-SI2016-04-15
00386120007854RELIPT556-PPT556-P2017-10-18
00386120008196RELI®PT556-MPT556-M2019-05-13
00386120009735RELI®PT1001-MPT1001-M2019-05-13
00386120009742RELI®PT1002-MPT1002-M2019-05-13
00386120009773RELI®PT7773-MPT7773-M2019-05-13
00386120014227RELI®SBCS21G-122026-02-02
00386120014234RELI®SBCS23G-122026-02-02
00386120014241RELI®SBCS25G-122026-02-02
10386120014224RELI®SBCS21G-122026-02-02
10386120014231RELI®SBCS23G-122026-02-02
10386120014248RELI®SBCS25G-122026-02-02
00386120014128RELISBCN-R20G1012025-11-21
00386120014135RELISBCN-R20G1142025-11-21
00386120014142RELISBCN-R20G1512025-11-21
00386120014159RELISBCN-R21G1012025-11-21
00386120014166RELISBCN-R21G1142025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17340179900122EndoDrill Drive System USBibbinstruments ABFCG2026-10-15
00817295020589InradInradKNW2026-10-09
00817295021081InradInradFCG2026-10-08
00817295021081InradInradKNW2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021388InradInradKNW2026-10-08
00817295021388InradInradFCG2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25