EPS Plating System

GUDID B471222000190

Locking Drill Guide, EPS Plates

GRAMERCY EXTREMITY ORTHOPEDICS LLC

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Primary Device IDB471222000190
NIH Device Record Key958c5643-ff26-4970-9df0-4767e1d0cbc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPS Plating System
Version Model Number22200019
Company DUNS080068420
Company NameGRAMERCY EXTREMITY ORTHOPEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB471222000190 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23

On-Brand Devices [EPS Plating System]

B471712400010Plate Bender (2) Pack 1.5mm
B471222000190Locking Drill Guide, EPS Plates
B471211191350Cannulated Drill, AO, 1.9mm x 135mm
B471200199150Driver Tip Hexalobe T-15 Solid 100mm
B471701200020Instrument Kit for EPS Plate, Long Screws

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