FDA.reportPublic FDA data

Theragenics

Primary DI
00813787021744
Brand
Theragenics
Company
THERAGENICS CORPORATION
Model
CPPS-MN-1821-25
Device description
18ga x 20cm Brachytherapy Applicator Needle, Yellow
Published
2022-04-26
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
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974118000WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLC1998-01-23IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813787021744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813787021744008137870217448137870217440813787021744

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy needleA sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
114379522
Device count
1
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
00813787021737TheragenicsCPPS-MN-1821-12022-04-26
00813787021751TheragenicsCPPS-MN-1821-52022-04-26
00813787021911TheragenicsCPPS-1820X-202021-04-28
00813787022031TheragenicsCPPS-SQ-1820X-NS2021-04-12
00813787022048TheragenicsCPPS-BT-1820X-NS2021-04-12
00813787021980TheragenicsCPPS-SQ-1830X-12020-09-22
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
00813787021195AnchorMarkerAM0845SL3-12016-02-02
00813787021201AnchorMarkerAM0845SL3-32016-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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