EPS Plating System

GUDID B471701200020

Instrument Kit for EPS Plate, Long Screws

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: B471701200020
• NIH Device Record Key: c2a0421b-3c89-4f3f-9030-eb10119679f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPS Plating System
• Version Model Number: 70120002
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471701200020 [Primary]

FDA Product Code

• KDD: Kit, surgical instrument, disposable

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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [EPS Plating System]

• B471712400010: Plate Bender (2) Pack 1.5mm
• B471222000190: Locking Drill Guide, EPS Plates
• B471211191350: Cannulated Drill, AO, 1.9mm x 135mm
• B471200199150: Driver Tip Hexalobe T-15 Solid 100mm
• B471701200020: Instrument Kit for EPS Plate, Long Screws