RIVERPOINT BRACHYTHERAPY

GUDID 00812444022124

BRACHYHERAPY

RIVERPOINT MEDICAL, LLC

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 00812444022124
• NIH Device Record Key: 5faf765e-4cf6-43b6-be73-65c0a56a7840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVERPOINT BRACHYTHERAPY
• Version Model Number: GM1053-1820
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444022124 [Primary]
GS1	10812444022121 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20812444022128 [Package]; Package: [9 Units]; In Commercial Distribution
GS1	30812444022125 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103449

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-12
• Device Publish Date: 2015-10-22

On-Brand Devices [RIVERPOINT BRACHYTHERAPY]

• 10812444023548: SUTURE
• 00812444024289: BRACHYTHERAPY
• 00812444024272: BRACHYTHERAPY
• 00812444024234: BRACHYTHERAPY
• 00812444023534: BRACHYTHERAPY
• 00812444023503: BRACHYTHERAPY
• 00812444023497: BRACHYTHERAPY
• 00812444023473: BRACHYTHERAPY
• 00812444023466: BRACHYTHERAPY
• 00812444023442: BRACHYTHERAPY
• 00812444023435: BRACHYTHERAPY
• 00812444023428: BRACHYTHERAPY
• 00812444023411: BRACHYTHERAPY
• 00812444023220: BRACHYTHERAPY
• 00812444023213: BRACHYTHERAPY
• 00812444023206: BRACHYTHERAPY
• 00812444023190: BRACHYTHERAPY
• 00812444023183: BRACHYTHERAPY
• 00812444022964: BRACHYTHERAPY
• 00812444022940: BRACHYTHERAPY
• 00812444022933: BRACHYTHERAPY
• 00812444022919: BRACHYTHERAPY
• 00812444022292: BRACHYTHERAPY
• 00812444022285: BRACHYTHERAPY
• 00812444022278: BRACHYTHERAPY
• 00812444022261: BRACHYTHERAPY
• 00812444022254: BRACHYTHERAPY
• 00812444022247: BRACHYTHERAPY
• 00812444022216: BRACHYTHERAPY
• 00812444022193: BRACHYTHERAPY
• 00812444022186: BRACHYTHERAPY
• 00812444022179: BRACHYTHERAPY
• 00812444022162: BRACHYTHERAPY
• 00812444022155: BRACHYTHERAPY
• 00812444022148: BRACHYTHERAPY
• 00812444022131: BRACHYTHERAPY
• 00812444022124: BRACHYHERAPY
• 00812444022117: BRACHYTHERAPY
• 00812444022100: BRACHYTHERAPY
• 00812444022094: BRACHYTHERAPY
• 00812444022087: BRACHYTHERAPY
• 00812444022070: BRACHYTHERAPY
• 00812444022056: BRACHYTHERAPY
• 00812444021691: BRACHYTHERAPY
• 00812444021684: BRACHYTHERAPY
• 00812444021660: BRACHYTHERAPY
• 00812444020472: BRACHYTHERAPY
• 00812444020465: BRACHYTHERAPY
• 00812444020441: Brachytherapy
• 00812444020434: Brachytherapy