DynaBunion 1500-48RD

GUDID 00850038154646

DynaBunion IMA Reducer - Disposable Sterile

CROSSROADS EXTREMITY SYSTEMS

Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00850038154646
• NIH Device Record Key: 6a59ed3a-564c-4cc9-bd4e-6b48bdacd983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaBunion
• Version Model Number: IMA Reducer - Disposable
• Catalog Number: 1500-48RD
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• 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	00850038154646 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [DynaBunion]

• 00850038154226: 1500-48FH
• 00850038154189: The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabili
• 00850038154646: DynaBunion IMA Reducer - Disposable Sterile
• 00850038154486: DynaBunion Plate STD 18mm Right
• 00850038154462: DynaBunion Plate STD 18mm - Left Sterile
• 00850038154479: DynaBuion Plate STD 15mm - Right Sterile
• 00850038154455: DynaBunion Plate STD 15mm - Left Sterile
• 00810112598247: DynaBunion RACBlock, Size 2
• 00810112598230: DynaBunion RACBlock, Size 1
• 00810112598193: DynaBunion RAC Block, Size 0
• 00810112598285: Compressor Block, Size 3