FDA.reportPublic FDA data

Dummy, silver, type COE

Primary DI
04049223104887
Brand
Dummy, silver, type COE
Company
Eckert & Ziegler BEBIG GmbH
Model
AGD.A31
Catalog number
AGD.A31
Published
2015-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K931393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931393000BEBIG PLAQUES RUM101-RUM114Bebig, Inc.1994-03-16KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049223104887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049223104887040492231048874049223104887

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, temporary placementA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry environment (relative humidity < 95%). Make sure that the packaging is not damaged, and that no chemicals are in close proximity to the storage location.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4930941084130info@bebig.com

Regulatory Flags#

DUNS number
331080432
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049223114527CT/MR Obturator for Plastic Needle, L= 300 mm (à 1 pc)LLH02-300LLH02-3002016-10-10
04049223104047Opening Forceps for Holding DiscsLAH05-03#05LAH05-032020-12-21
04049223132088SagiPlan® 2.x Software1374-0600#031374-06002020-07-01
04049223132613Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)LAA1400-GYN#02LAA1400-GYN2020-03-31
04049223133634Universal Applicator, marked, D=2mm, L=1200mm (sterile)LLA1200-20#04LLA1200-202020-03-31
04049223101077Flexible Catheter Single Leader, D=1.65mm, L=300mmLLA300-F#02-SPLLA300-F2016-10-06
04049223101169Plastic Needle, D=1.65mm, L=150mm, 16GLLA150-KB#02-SPLLA150-KB2016-10-06
04049223101176Plastic Needle, D=1.65mm, L=200mm, 16GLLA200-KB#02-SPLLA200-KB2016-10-06
04049223101183Plastic Needle, D=1.65mm, L=300mm, 16GLLA300-KB#02-SPLLA300-KB2016-10-06
04049223101190Cutter for flexible CathetersLAH06-01#03LAH06-012016-10-05
04049223101206CT/MR Intrauterine Tube straight, thin, D=3.5mmLCT01-01#03LCT01-012016-10-07
04049223101213CT/MR Intrauterine Tube 15°, thin, D=3.5mm, IUL=25mmLCT02-01#03LCT02-012016-10-07
04049223101220CT/MR Intrauterine Tube 20°, thin, D=3.5mm, IUL=30mmLCT03-01#03LCT03-012016-10-07
04049223101237CT/MR Intrauterine Tube 25°, thin, D=3.5mm, IUL=35mmLCT04-01#03LCT04-012016-10-07
04049223101244CT/MR Intrauterine Tube 40°, thin, D=3.5mm, IUL=35mmLCT05-01#03LCT05-012016-10-07
04049223101251CT/MR Intrauterine Tube 30°, thin, D=3.5mm, IUL=65mmLCT06-01#03LCT06-012016-10-07
04049223101770CT/MR Fletcher Ovoid Tubes right and leftLCT82-02#03LCT82-022016-10-07
04049223102722Vaginal Cylinder with variable length, D=20mm, L=120mmLAZ07-01#04LAZ07-012016-10-07
04049223102739CT/MR-Vag. Cylinder with variable length D=20mm L=120mmLCZ07-01#04LCZ07-012016-10-07
04049223102784Channel Coding for Needles and Catheters (Channel 1)LLZ03-01LLZ03-012016-10-10

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