SILVERBOLT 2 PEDICLE SCREW SYSTEM

GUDID 00840996160308

SBOLT,TORQ HANDLE SQ DRV, 60 INLB

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996160308
• NIH Device Record Key: aacc2a54-33f9-4cfd-bfe6-7ef51f44e6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILVERBOLT 2 PEDICLE SCREW SYSTEM
• Version Model Number: BSK-8703
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996160308 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996160308]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-26

On-Brand Devices [SILVERBOLT 2 PEDICLE SCREW SYSTEM]

• 00840996160308: SBOLT,TORQ HANDLE SQ DRV, 60 INLB
• 00840996187381: SILVERBOLT,GUIDEWIRES,BLUNT,NONSTERILE
• 00840996187374: SILVERBOLT,GUIDEWIRES,NONSTERILE