FirstFUSE 1st MTP Joint Plating System

GUDID B471120200050

MTPJ Plate Small Right, 0 deg Dorsiflexion/5 deg Abduction, EPS

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: B471120200050
• NIH Device Record Key: 55dbe855-50ba-4723-a1cb-a119d57e437c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FirstFUSE 1st MTP Joint Plating System
• Version Model Number: 12020005
• Company DUNS: 080068420
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471120200050 [Primary]

FDA Product Code

• HRS: Plate, fixation, bone

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: 2020-11-02
• Device Publish Date: 2020-10-23

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• B471120200500: MTPJ Plate Small Right, 5 deg Dorsiflexion/0 deg Abduction, EPS
• B471120200050: MTPJ Plate Small Right, 0 deg Dorsiflexion/5 deg Abduction, EPS
• B471120200000: MTPJ Plate Small Right, 0 deg Dorsiflexion/0 deg Abduction, EPS