InstaFix Shape Memory Fixation System 400-3715

GUDID B04140037150

OT MEDICAL, LLC

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: B04140037150
• NIH Device Record Key: b48695cf-3bff-4652-9985-08c33bcba7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaFix Shape Memory Fixation System
• Version Model Number: 400-3715
• Catalog Number: 400-3715
• Company DUNS: 078738154
• Company Name: OT 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: 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

Customer Support Contacts

• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com
• Phone: (484) 588-2063
• Email: wrhoda@otmedco.com

Device Dimensions

• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 17 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B04140037150 [Primary]

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-14

On-Brand Devices [InstaFix Shape Memory Fixation System]

• B04140037250: 400-3725
• B04140037240: 400-3724
• B04140037230: 400-3723
• B04140037220: 400-3722
• B04140037210: 400-3721
• B04140037150: 400-3715
• B04140037090: 400-3709
• B04140037030: 400-3703
• B04140037010: 400-3701