FDA.reportPublic FDA data

Dummy, silver, type COB

Primary DI
04049223104863
Brand
Dummy, silver, type COB
Company
Eckert & Ziegler BEBIG GmbH
Model
AGD.A29
Catalog number
AGD.A29
Published
2015-09-24
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
04049223104863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049223104863040492231048634049223104863

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
M936PDIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
00841365121531Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-05-04
00841365121500Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-04-03
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
00841365121388Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-10-20
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15S9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15SS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
00860000064545GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
20860000064549GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064569CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064576CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064583PL-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064590PL-5GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485407PL-2GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485414PL-3GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485421PL-4GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485438PL-4NSGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485445PL-5MGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485452PL-7GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485469PL-8GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00841365120688Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-03-14
00841365120640Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-01-29
00850800006067VariSeedVARIAN MEDICAL SYSTEMS, INC.KXK2023-09-15
00841365120503Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120510Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120213Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-03-29
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03