Reusable Frame, Bard SurePoint Stepper

GUDID 00852656007182

The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.

Best Nomos

Nonimplantable needle guide, reusable

• Primary Device ID: 00852656007182
• NIH Device Record Key: d58276d9-f90d-4b31-a089-dfc9edf91ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Frame, Bard SurePoint Stepper
• Version Model Number: 6051
• Company DUNS: 146920025
• Company Name: Best Nomos
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (412) 312-6700
• Email: info@nomos.com
• Phone: (412) 312-6700
• Email: info@nomos.com
• Phone: (412) 312-6700
• Email: info@nomos.com
• Phone: (412) 312-6700
• Email: info@nomos.com
• Phone: (412) 312-6700
• Email: info@nomos.com
• Phone: (412) 312-6700
• Email: info@nomos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852656007182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973786

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

[00852656007182]

Moist Heat or Steam Sterilization

[00852656007182]

Moist Heat or Steam Sterilization

[00852656007182]

Moist Heat or Steam Sterilization

[00852656007182]

Moist Heat or Steam Sterilization

[00852656007182]

Moist Heat or Steam Sterilization

[00852656007182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-10-31

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