FDA.reportPublic FDA data

Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single Pack

Primary DI
00815165020417
Brand
Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single Pack
Company
Eckert & Ziegler Bebig, Inc.
Model
PSS1820SL3 Round Hub Needles, Single Pack
Catalog number
MO845SL3-1
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815165020417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815165020417008151650204178151650204170815165020417

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile 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 formed as a wire, needle, bead, stent-like tube or washer, 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
203-262-0571ned.lanfranco@bebig.com

Regulatory Flags#

DUNS number
021125001
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815165020394Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub NeedlePSS1820SLS Round Hub NeedleCAM0845SLS-12015-10-27
00815165020011AnchorLoad Brachytherapy Kit - Loose LoadAnchorLoad Brachytherapy Kit - Loose Load ALKITLL 2015-10-27
00815165020035AnchorLoad Brachytherapy Kit I125 - Loose LoadAnchorLoad Brachytherapy Kit I125 - Loose LoadALKITI125LL2015-10-27
00815165020103Echo RTS Brachytherapy KitEcho RTS Brachytherapy KitERTSKIT2015-10-27
00815165020141EchoStrand Brachytherapy Kit I-125EchoStrand Brachytherapy Kit I-125 ESKITI125 2015-10-27
00815165020172RTS Brachytherapy Kit I-125RTS Brachytherapy Kit I-125RTSKITI1252015-10-27
00815165020189RTS Brachytherapy Kit PD103RTS Brachytherapy Kit PD103RTSKITPD1032015-10-27
00815165020240Spacer 5.5mm Synthetic 150 pieceSpacer 5.5mm Synthetic 150 pieceSS9X551502015-10-27
00815165020271Spacer 5cm Synthetic 5 pieceSpacer 5cm Synthetic 5 pieceSS9X5CMS2015-10-27
00815165020721Applicator Brachytherapy KitApplicator Brachytherapy Kit I125APPNSI1252015-10-27
00081516502001AnchorLoad Brachytherapy Kit - Loose LoadAnchorLoad Brachytherapy Kit - Loose Load ALKITLL 2015-10-27
00081516502003AnchorLoad Brachytherapy Kit I125 - Loose LoadAnchorLoad Brachytherapy Kit I125 - Loose LoadALKITI125LL2015-10-27
00081516502004AnchorLoad Brachytherapy Kit PD103AnchorLoad Brachytherapy Kit PD103AKITIPD1032015-10-27
00081516502010Echo RTS Brachytherapy KitEcho RTS Brachytherapy KitERTSKIT2015-10-27
00081516502011EchoStrand Brachytherapy KitEchoStrand Brachytherapy KitESKIT2015-10-27
00081516502014EchoStrand Brachytherapy Kit I-125EchoStrand Brachytherapy Kit I-125 ESKITI125 2015-10-27
00081516502017RTS Brachytherapy Kit I-125RTS Brachytherapy Kit I-125RTSKITI1252015-10-27
00081516502018RTS Brachytherapy Kit PD103RTS Brachytherapy Kit PD103RTSKITPD1032015-10-27
00081516502024Spacer 5.5mm Synthetic 150 pieceSpacer 5.5mm Synthetic 150 pieceSS9X551502015-10-27
00081516502027Spacer 5cm Synthetic 5 pieceSpacer 5cm Synthetic 5 pieceSS9X5CMS2015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556330328053126035Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655635032805302533Implant NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655662032805302615Intrauterine TandemLiberty Medical , Inc.IWJ2026-06-01
B16558010327123126103Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558010328010026067Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-06-01
B16559050328053126091ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559060328053026074ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559090328053026060ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559100328053026079ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16570160328053126101Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570170328053126102Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570940328053126107AdapterLiberty Medical , Inc.IWJ2026-06-01
00841365121579Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-29
00841365121562Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-21
00841365121555Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-15
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.IWJ2026-05-11
00841365121548Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-06
B165565003280430252241Small Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B16556510328043026077Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B165576403280430260101Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557640328043026081Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557650328040025244Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16570170328043026057Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
00841365121524Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-29
00841365121517Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-16