GAP ENDO-EXO MEDULLARY SYSTEM GAP-IME200

GUDID 07540194016836

GAP 2.0 EMPTY IMPLANT CASE 1 - NAIL

Pega Medical Inc

Surgical instrument/implant rack
Primary Device ID07540194016836
NIH Device Record Keye90494a5-3c8f-426a-a5cb-000cc7f0f3b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGAP ENDO-EXO MEDULLARY SYSTEM
Version Model NumberGAP-IME200
Catalog NumberGAP-IME200
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca
Phone+1(450)688-5144
Emailegarcia@orthopediatrics.ca

Device Dimensions

Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter
Length150 Millimeter
Outer Diameter1.95 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194016836 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

[07540194016836]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-19
Device Publish Date2024-09-11

On-Brand Devices [GAP ENDO-EXO MEDULLARY SYSTEM]

07540194004857Cortical Peg & Washer Ø2.5mm X 80mm
07540194004840Cortical Peg & Washer Ø2.5mm X 75mm
07540194004833Cortical Peg & Washer Ø2.5mm X 70mm
07540194004826Cortical Peg & Washer Ø2.5mm X 65mm
07540194004819Cortical Peg & Washer Ø2.5mm X 55mm
07540194004802Cortical Peg & Washer Ø2.5mm X 50mm
07540194004796Cortical Peg & Washer Ø2.5mm X 45mm
07540194004789Cortical Peg & Washer Ø2.5mm X 40mm
07540194004772Cortical Peg & Washer Ø2.5mm X 38mm
07540194004765Cortical Peg & Washer Ø2.5mm X 36mm
07540194004758Cortical Peg & Washer Ø2.5mm X 34mm
07540194004741Cortical Peg & Washer Ø2.5mm X 32mm
07540194004734Cortical Peg & Washer Ø2.5mm X 30mm
07540194004727Cortical Peg & Washer Ø2.5mm X 28mm
07540194004710Cortical Peg & Washer Ø2.5mm X 26mm
07540194004703Cortical Peg & Washer Ø2.5mm X 24mm
07540194004697Cortical Peg & Washer Ø2.5mm X 22mm
07540194004680Cortical Peg & Washer Ø2.5mm X 20mm
07540194004673Cortical Peg Ø2.5mm X 80mm
07540194004666Cortical Peg Ø2.5mm X 75mm
07540194004659Cortical Peg Ø2.5mm X 70mm
07540194004642Cortical Peg Ø2.5mm X 65mm
07540194004635Cortical Peg Ø2.5mm X 55mm
07540194004628Cortical Peg Ø2.5mm X 50mm
07540194004611Cortical Peg Ø2.5mm X 45mm
07540194004604Cortical Peg Ø2.5mm X 40mm
07540194004598Cortical Peg Ø2.5mm X 38mm
07540194004581Cortical Peg Ø2.5mm X 36mm
07540194004574Cortical Peg Ø2.5mm X 34mm
07540194004567Cortical Peg Ø2.5mm X 32mm
07540194004550Cortical Peg Ø2.5mm X 30mm
07540194004543Cortical Peg Ø2.5mm X 28mm
07540194004536Cortical Peg Ø2.5mm X 26mm
07540194004529Cortical Peg Ø2.5mm X 24mm
07540194004512Cortical Peg Ø2.5mm X 22mm
07540194004505Cortical Peg Ø2.5mm X 20mm
07540194004499Cortical Peg & Washer Ø2.5mm X 60mm
07540194004352FULL GAP IMPLANT CASE
07540194004345Cortical Peg Ø2.5mm X 60mm
07540194002235Semi-Spherical Nut A/F 6.0mm
07540194002228Short Fixation Plate
07540194002211Long Fixation Plate
07540194002204Nail Cap 10.0mm High
07540194002198Nail Cap 5.0mm High
07540194002181Nail Cap 1.5mm High
07540194002174Mechanical Screw Ø4.0mm X 34mm
07540194002167Mechanical Screw Ø4.0mm X 24mm
07540194002150Coxa Vara Plate Large
07540194002143Coxa Vara Plate Medium
07540194002136Coxa Vara Plate Small
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