FDA.reportPublic FDA data

Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle

Primary DI
00815165020400
Brand
Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle
Company
Eckert & Ziegler Bebig, Inc.
Model
PSS1820SLS Round Hub Needle
Catalog number
CMS0845SL3-1
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
00815165020400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815165020400008151650204008151650204000815165020400

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy source spacerA sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.

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
00815165020417Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single PackPSS1820SL3 Round Hub Needles, Single PackMO845SL3-12015-10-27
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

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