EPS Plating System Screw

GUDID B471110340420

Plate Screw Non-Locking Cancellous 4.0mm x 42mm, EPS

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB471110340420
NIH Device Record Key61034f85-0566-4763-8b40-4e1732315077
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPS Plating System Screw
Version Model Number11034042
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
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com

Device Dimensions

Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter
Length42 Millimeter
Outer Diameter4 Millimeter

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
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
HIBCCB471110340420 [Primary]

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-18
Device Publish Date2022-01-10

On-Brand Devices [EPS Plating System Screw]

B471111235400Plate Screw Fixed Angle Locking Cortical 3.5 x 40mm, EPS
B471111235380Plate Screw Fixed Angle Locking Cortical 3.5 x 38mm, EPS
B471111235360Plate Screw Fixed Angle Locking Cortical 3.5 x 36mm, EPS
B471111235340Plate Screw Fixed Angle Locking Cortical 3.5 x 34mm, EPS
B471111235320Plate Screw Fixed Angle Locking Cortical 3.5 x 32mm, EPS
B471111235300Plate Screw Fixed Angle Locking Cortical 3.5 x 30mm, EPS
B471111235280Plate Screw Fixed Angle Locking Cortical 3.5 x 28mm, EPS
B471111235260Plate Screw Fixed Angle Locking Cortical 3.5 x 26mm, EPS
B471111235240Plate Screw Fixed Angle Locking Cortical 3.5 x 24mm, EPS
B471111235220Plate Screw Fixed Angle Locking Cortical 3.5 x 22mm, EPS
B471111235200Plate Screw Fixed Angle Locking Cortical 3.5 x 20mm, EPS
B471111235180Plate Screw Fixed Angle Locking Cortical 3.5 x 18mm, EPS
B471111235160Plate Screw Fixed Angle Locking Cortical 3.5 x 16mm, EPS
B471111235140Plate Screw Fixed Angle Locking Cortical 3.5 x 14mm, EPS
B471111235120Plate Screw Fixed Angle Locking Cortical 3.5 x 12mm, EPS
B471111235100Plate Screw Fixed Angle Locking Cortical 3.5 x 10mm, EPS
B471111227400Plate Screw Fixed Angle Locking Cortical 2.7 x 40mm, EPS
B471111227380Plate Screw Fixed Angle Locking Cortical 2.7 x 38mm, EPS
B471111227360Plate Screw Fixed Angle Locking Cortical 2.7 x 36mm, EPS
B471111227340Plate Screw Fixed Angle Locking Cortical 2.7 x 34mm, EPS
B471111227320Plate Screw Fixed Angle Locking Cortical 2.7 x 32mm, EPS
B471111227300Plate Screw Fixed Angle Locking Cortical 2.7 x 30mm, EPS
B471111227280Plate Screw Fixed Angle Locking Cortical 2.7 x 28mm, EPS
B471111227260Plate Screw Fixed Angle Locking Cortical 2.7 x 26mm, EPS
B471111227240Plate Screw Fixed Angle Locking Cortical 2.7 x 24mm, EPS
B471111227220Plate Screw Fixed Angle Locking Cortical 2.7 x 22mm, EPS
B471111227200Plate Screw Fixed Angle Locking Cortical 2.7 x 20mm, EPS
B471111227180Plate Screw Fixed Angle Locking Cortical 2.7 x 18mm, EPS
B471111227160Plate Screw Fixed Angle Locking Cortical 2.7 x 16mm, EPS
B471111227140Plate Screw Fixed Angle Locking Cortical 2.7 x 14mm, EPS
B471111227120Plate Screw Fixed Angle Locking Cortical 2.7 x 12mm, EPS
B471111227100Plate Screw Fixed Angle Locking Cortical 2.7 x 10mm, EPS
B471110340400Plate Screw Non-Locking Cancellous 4.0 x 40mm, EPS
B471110340380Plate Screw Non-Locking Cancellous 4.0 x 38mm, EPS
B471110340360Plate Screw Non-Locking Cancellous 4.0 x 36mm, EPS
B471110340340Plate Screw Non-Locking Cancellous 4.0 x 34mm, EPS
B471110340320Plate Screw Non-Locking Cancellous 4.0 x 32mm, EPS
B471110340300Plate Screw Non-Locking Cancellous 4.0 x 30mm, EPS
B471110340280Plate Screw Non-Locking Cancellous 4.0 x 28mm, EPS
B471110340260Plate Screw Non-Locking Cancellous 4.0 x 26mm, EPS
B471110340240Plate Screw Non-Locking Cancellous 4.0 x 24mm, EPS
B471110340220Plate Screw Non-Locking Cancellous 4.0 x 22mm, EPS
B471110340200Plate Screw Non-Locking Cancellous 4.0 x 20mm, EPS
B471110340180Plate Screw Non-Locking Cancellous 4.0 x 18mm, EPS
B471110340160Plate Screw Non-Locking Cancellous 4.0 x 16mm, EPS
B471110340140Plate Screw Non-Locking Cancellous 4.0 x 14mm, EPS
B471110340120Plate Screw Non-Locking Cancellous 4.0 x 12mm, EPS
B471110340100Plate Screw Non-Locking Cancellous 4.0 x 10mm, EPS
B471110240400Plate Screw Non-Locking Cortical 4.0 x 40mm, EPS
B471110240380Plate Screw Non-Locking Cortical 4.0 x 38mm, EPS
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