FREE GLIDING SCFE SCREW SYSTEM SCF-MC-065

GUDID 07540194002396

Cap Ø6.5mm

Pega Medical Inc

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID07540194002396
NIH Device Record Key0dc0e51e-3904-4985-b045-399ae17f48d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREE GLIDING SCFE SCREW SYSTEM
Version Model NumberSCF-MC-065
Catalog NumberSCF-MC-065
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com

Device Dimensions

Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194002396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

[07540194002396]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-20

On-Brand Devices [FREE GLIDING SCFE SCREW SYSTEM]

07540194006011COMBINED SCFE CASE, 3rd Gen.
07540194004451FULL SCFE IMPLANT & INSTRUMENT CASE 2nd Gen.
07540194004376FULL MINI SCFE IMPLANT CASE
07540194004369FULL SCFE IMPLANT & INSTRUMENT CASE
07540194004307Female Component 100/102mm Ø7.3mm
07540194004291Female Component 100/102mm Ø6.5mm
07540194002594Male Component Ø6.5mm Short
07540194002587Male Component Ø6.5mm Long
07540194002570Cap Ø7.3mm
07540194002563Female Component 96/98mm Ø7.3mm
07540194002556Female Component 92/94mm Ø7.3mm
07540194002549Female Component 88/90mm Ø7.3mm
07540194002532Female Component 84/86mm Ø7.3mm
07540194002525Female Component 80/82mm Ø7.3mm
07540194002518Female Component 76/78mm Ø7.3mm
07540194002501Female Component 72/74mm Ø7.3mm
07540194002495Female Component 68/70mm Ø7.3mm
07540194002488Female Component 64/66mm Ø7.3mm
07540194002471Female Component 60/62mm Ø7.3mm
07540194002464Mini Female Component 56/58mm Ø7.3mm
07540194002457Mini Female Component 52/54mm Ø7.3mm
07540194002440Mini Female Component 48/50mm Ø7.3mm
07540194002433Mini Male Component Ø7.3mm Short
07540194002426Mini Male Component Ø7.3mm Long
07540194002419Male Component Ø7.3mm Short
07540194002402Male Component Ø7.3mm Long
07540194002396Cap Ø6.5mm
07540194002389Female Component 96/98mm Ø6.5mm
07540194002372Female Component 92/94mm Ø6.5mm
07540194002365Female Component 88/90mm Ø6.5mm
07540194002358Female Component 84/86mm Ø6.5mm
07540194002341Female Component 80/82mm Ø6.5mm
07540194002334Female Component 76/78mm Ø6.5mm
07540194002327Female Component 72/74mm Ø6.5mm
07540194002310Female Component 68/70mm Ø6.5mm
07540194002303Female Component 64/66mm Ø6.5mm
07540194002297Female Component 60/62mm Ø6.5mm
07540194002280Mini Female Component 56/58mm Ø6.5mm
07540194002273Mini Female Component 52/54mm Ø6.5mm
07540194002266Mini Female Component 48/50mm Ø6.5mm
07540194002259Mini Male Component Ø6.5mm Short
07540194002242Mini Male Component Ø6.5mm Long
07540194010988SCFE HANDLE-SHAFT SUBASSY Ø7.3mm - MINI
07540194010971SCFE HANDLE-SHAFT SUBASSY Ø6.5mm - MINI
07540194009715FULL SCFE IMPLANT & INSTRUMENT CASE RENTAL - GENERATION III
07540194009708FULL SCFE IMPLANT & INSTRUMENT CASE RENTAL – GENERATION II
07540194009692FULL MINI SCFE IMPLANT CASE RENTAL
07540194010865SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 6
07540194010858SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 2
07540194008268SCFE GUIDE WIRE CoCr Ø2.80mm x 330mm
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