Theragenics

GUDID 00813787021362

THERAGENICS CORPORATION

Brachytherapy source spacer

• Primary Device ID: 00813787021362
• NIH Device Record Key: 274c972f-01df-46be-9070-e70e89d96f82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theragenics
• Version Model Number: PSS-910-50-50
• Company DUNS: 114379522
• Company Name: THERAGENICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813787021362 [Primary]

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00813787021362]

Ethylene Oxide

[00813787021362]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-06

On-Brand Devices [Theragenics]

• 00813787021782: 18g 20cm Pre-waxed Brachytherapy Needle, Box of 25
• 00813787021775: 18g 20cm Pre-waxed Brachytherapy Needle, 5 pack
• 00813787021768: 18g 20cm Pre-waxed Brachytherapy Needle, 1 pack
• 00813787021669: Bio Spacer 910 5.0mm, Nonsterile, QTY 50
• 00813787021652: Bio Spacer 910 5.5mm, Nonsterile, QTY 150
• 00813787021638: XX72xLV
• 00813787021614: XX72xiLV
• 00813787021607: CPPS-BT-1820-1
• 00813787021591: CPPS-SQ-1820-5
• 00813787021584: CPPS-BT-1820-1
• 00813787021577: CPPS-BT-1820-5
• 00813787021560: CPPS-MN-1825-1
• 00813787021553: CPPS-MN-1825-5
• 00813787021546: CPPS-MN-1720-1
• 00813787021539: CPPS-MN-1720-5
• 00813787021522: CPPS-MN-1820-1
• 00813787021515: CPPS-MN-1820-5
• 00813787021508: CPPS-SQ-1820
• 00813787021492: CPPS-BT-1820
• 00813787021485: CPPS-1720X-1
• 00813787021478: CPPS-1720X-5
• 00813787021461: CPPS-1720X
• 00813787021454: 813787021454
• 00813787021447: CPPS-1820X-5
• 00813787021430: CPPS-1820X
• 00813787021423: CPPS-SQ-1820X-1
• 00813787021416: CPPS-SQ-1820X-5
• 00813787021409: CPPS-SQ-1820X
• 00813787021393: CPPS-MN-1825
• 00813787021386: CPPS-MN-1720
• 00813787021379: CPPS-MN-1820
• 00813787021362: PSS-910-50-50
• 00813787021355: PSS-910-55-20
• 00813787021348: PSS-910-55-50
• 00813787021102: Sterile Loose Gold Markers 1.0mm X 5.0mm (1)
• 00813787021096: Gold Fiducial Marker Needles (18g) 1.0mm X 7.0mm (3)
• 00813787021089: Gold Fiducial Marker Needles (18g) 1.0mm X 7.0mm (1)
• 00813787021072: Gold Fiducial Marker Needles (18g) 1.0mm X 5.0mm (3)
• 00813787021065: Gold Fiducial Marker Needles (18g) 1.0mm X 5.0mm (1)
• 00813787021058: Gold Fiducial Marker Needles (18g) 1.0mm X 3.0mm (3)
• 00813787021041: Gold Fiducial Marker Needles (18g) 1.0mm X 3.0mm (1)
• 00813787021034: Gold Fiducial Marker Needles (17g) 1.2mm X 7.0mm (3)
• 00813787021027: Gold Fiducial Marker Needles (17g) 1.2mm X 7.0mm (1)
• 00813787021010: Gold Fiducial Marker Needles (17g) 1.2mm X 5.0mm (3)
• 00813787021003: Gold Fiducial Marker Needles (17g) 1.2mm X 5.0mm (1)
• 00813787020990: Gold Fiducial Marker Needles (17g) 1.2mm X 3.0mm (3)
• 00813787020983: Gold Fiducial Marker Needles (17g) 1.2mm X 3.0mm (1)
• 00813787021836: 0811-1
• 00813787021867: 0811-53
• 00813787021850: 0811-51