CRP™ Cuff Repair Plate System 45-IM-AB045

GUDID 00815482020039

Anchor Bolt, 45mm

Shoulder Options, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00815482020039
• NIH Device Record Key: 05e6eb1d-60fb-4595-aad8-fd6453a00586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRP™ Cuff Repair Plate System
• Version Model Number: 45-IM-AB045
• Catalog Number: 45-IM-AB045
• Company DUNS: 053545528
• Company Name: Shoulder Options, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com

Device Dimensions

• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815482020039 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00815482020039]

Moist Heat or Steam Sterilization

[00815482020039]

Moist Heat or Steam Sterilization

[00815482020039]

Moist Heat or Steam Sterilization

[00815482020039]

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: 2015-11-02

On-Brand Devices [CRP™ Cuff Repair Plate System]

• 00815482020213: 4.5mm QC/AO Handle
• 00815482020206: Crochet Hook
• 00815482020190: Penetrating Awl
• 00815482020183: 2.5mm Small Hex Screwdriver with Spring Tip
• 00815482020176: CRP Guide's Guide Handle
• 00815482020169: Depth Gauge
• 00815482020152: 4.5mm Threaded Drill Guide
• 00815482020145: 4.5mm Drill Bit
• 00815482020138: 1.6 x 150mm K-Wire, trocar tip
• 00815482020121: CRP Guide's Guide, Left
• 00815482020114: CRP Guide's Guide, Right
• 00815482020107: Anchor Bolt, 10mm
• 00815482020091: Anchor Bolt, 15mm
• 00815482020084: Anchor Bolt, 20mm
• 00815482020077: Anchor Bolt, 25mm
• 00815482020060: Anchor Bolt, 30mm
• 00815482020053: Anchor Bolt, 35mm
• 00815482020046: Anchor Bolt, 40mm
• 00815482020039: Anchor Bolt, 45mm
• 00815482020022: Anchor Bolt, 50mm
• 00815482020015: CRP Plate, Left
• 00815482020008: CRP Plate, Right