FDA.reportPublic FDA data

Theragenics

Primary DI
00813787021652
Brand
Theragenics
Company
THERAGENICS CORPORATION
Model
PSS-910-55-150NS
Device description
Bio Spacer 910 5.5mm, Nonsterile, QTY 150
Published
2018-02-08
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

Product Codes#

Code, Name table
CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013964000MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERSCp Medical2002-01-24KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813787021652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813787021652008137870216528137870216520813787021652

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
Ethylene Oxide

Regulatory Flags#

DUNS number
114379522
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813787021799Theragenics0705-12020-07-15
00813787021805Theragenics0705-32020-07-15
00813787021812Theragenics0705-512020-07-15
00813787021829Theragenics0705-532020-07-15
00813787021843Theragenics0811-32020-07-15
00813787021850Theragenics0811-512020-07-15
00813787021867Theragenics0811-532020-07-15
00813787021836Theragenics0811-12020-07-08
00813787020983TheragenicsTG31212015-09-28
00813787020990TheragenicsTG31222015-09-28
00813787021003TheragenicsTG31232015-09-28
00813787021010TheragenicsTG31242015-09-28
00813787021027TheragenicsTG31252015-09-28
00813787021034TheragenicsTG31262015-09-28
00813787021041TheragenicsTG34272015-09-28
00813787021058TheragenicsTG34282015-09-28
00813787021065TheragenicsTG34292015-09-28
00813787021072TheragenicsTG34302015-09-28
00813787021089TheragenicsTG34312015-09-28
00813787021096TheragenicsTG34322015-09-28

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