FDA.reportPublic FDA data

Spacer 5cm Synthetic 5 piece

Primary DI
00081516502027
Brand
Spacer 5cm Synthetic 5 piece
Company
Eckert & Ziegler Bebig, Inc.
Model
Spacer 5cm Synthetic 5 piece
Catalog number
SS9X5CMS
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081516502027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081516502027000815165020270815165020270081516502027

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy systemAn assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in appliances and applicators for either permanent or temporary delivery at the topical, interstitial, intraluminal, or intracavitary brachytherapy treatment site. The radioactive source(s) assemblies contain naturally occurring, reactor produced, or accelerator produced radionuclides that are in the form of, e.g., encapsulated, embedded, sealed, wire, plated or foil sources, contained radioactive liquids, gels or gas.

Sterilization Methods#

Method table
Method

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
true
Lot or batch
true
Serial number
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
M936IRLS20S9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
M936IRLS20SS9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
10801741184120SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
10801741184137SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
00813787021799TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021805TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021812TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021829TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021843TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021850TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021867TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021836TheragenicsTHERAGENICS CORPORATIONKXK2020-07-08
00853162006430Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006447Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006577Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006607Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
B887MRTL050415200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050415210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050820210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075415190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075820190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTLS075920180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887PTTL050110210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887TL050215200VISICOILIzi Medical Products, LLCKXK2020-04-30