EPS Plating System

GUDID B471712400010

Plate Bender (2) Pack 1.5mm

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use Manual orthopaedic bender, single-use

• Primary Device ID: B471712400010
• NIH Device Record Key: f3e78104-a79d-4192-a921-778aa523d1e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPS Plating System
• Version Model Number: 71240001
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471712400010 [Primary]

FDA Product Code

• HXW: BENDER

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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