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
OTC
false
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
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.

Contacts#

Phone, Email table
PhoneEmail
203-262-0571ned.lanfranco@bebig.com

Regulatory Flags#

DUNS number
021125001
Device count
1
DM exempt
false
Premarket exempt
true
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
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

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B16570940328083126166AdapterLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126177AdapterLiberty Medical , Inc.IWJ2026-08-18
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B16557060328060026140Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B16558000327103126049Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558010328043026108Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558100328103126034Small Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-07-08
B16559070328063026073ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559080328063026059ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559100328063026111ButtonsLiberty Medical , Inc.IWJ2026-07-08
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