FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-032(SPS)-SS

GUDID 07540194000293

Short Tibial/Humeral Nail Assy Ø3.2 mm x 197mm

Pega Medical Inc

Humerus nail, sterile
Primary Device ID07540194000293
NIH Device Record Key11a6b604-afa4-49f5-ab4e-5530c4b82b71
Commercial Distribution StatusIn Commercial Distribution
Brand NameFASSIER-DUVAL TELESCOPIC IM SYSTEM
Version Model NumberFD-032(SPS)-SS
Catalog NumberFD-032(SPS)-SS
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

Device Dimensions

Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 Millimeter
Length197 Millimeter
Outer Diameter3.2 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194000293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

Moist Heat or Steam Sterilization

[07540194000293]

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 [FASSIER-DUVAL TELESCOPIC IM SYSTEM]

07540194006073FULL IMPLANTS STERILIZATION CASE
07540194006066FD MAIN IMPLANT CASE GEN2 – CONSIGNMENT
07540194000552LON Tibial/Humeral Assy Ø6.4mm x 401mm
07540194000545LON Femoral Nail Assy Ø6.4 mm x 401mm
07540194000538Short Tibial/Humeral Nail Assy Ø6.4mm x 407mm
07540194000521Short Proximal Long Distal Nail Assy Ø6.4mm x 412mm
07540194000514Short Femoral Nail Assy Ø6.4mm x 407mm
07540194000507Long Femoral Nail Assy Ø6.4mm x 412mm
07540194000491LON Tibial/ Humeral Nail Assy Ø5.6mm x 401mm
07540194000484LON Femoral Nail Assy Ø5.6 mm x 401mm
07540194000477Short Tibial/Humeral Nail Assy Ø5.6mm x 405mm
07540194000460Short Proximal Long Distal Nail Assy Ø5.6mm x 410mm
07540194000453Short Femoral Nail Assy Ø5.6mm x 405mm
07540194000446Long Femoral Nail Assy Ø5.6mm x 410mm
07540194000439LON Tibial/ Humeral Nail Assy Ø4.8mm x 400mm
07540194000422LON Femoral Nail Assy Ø4.8 mm x 400mm
07540194000415Short Tibial/Humeral Nail Assy Ø4.8mm x 404mm
07540194000408Short Proximal Long Distal Nail Assy Ø4.8mm x 409mm
07540194000392Short Femoral Nail Assy Ø4.8mm x 404mm
07540194000385Long Femoral Nail Assy Ø4.8mm x 409mm
07540194000378LON Tibial/Humeral Assy Ø4.0mm x 330mm
07540194000361LON Femoral Nail Assy Ø4.0 mm x 330mm
07540194000354Short Tibial/Humeral Nail Assy Ø4.0mm x 333mm
07540194000347Short Proximal Long Distal Nail Assy Ø4.0mm x 338mm
07540194000330Short Femoral Nail Assy Ø4.0mm x 333 mm
07540194000323Long Femoral Nail Assy Ø4.0mm x 338mm
07540194000316LON Tibial/ Humeral Nail Assy Ø3.2 mm x 194mm
07540194000309LON Femoral Nail Assy Ø3.2 mm x 194mm
07540194000293Short Tibial/Humeral Nail Assy Ø3.2 mm x 197mm
07540194000286Short Proximal Long Distal Nail Assy Ø3.2 mm x 202mm
07540194000279Short Femoral Nail Assy Ø3.2 mm x 197mm
07540194000262Long Femoral Nail Assy Ø3.2mm x 202mm
07540194000255Tibia/Humeral Female Component for Ø6.4mm Assy
07540194000248Tibia/Humeral Female Component for Ø5.6mm Assy
07540194000231Tibia/Humeral Female Component for Ø4.8mm Assy
07540194000224Tibia/Humeral Female Component for Ø4.0mm Assy
07540194000217Tibia/Humeral Female Component for Ø3.2mm Assy
07540194000200Male LON Component for Ø6.4mm Assy
07540194000194Male Long Component for Ø6.4mm Assy
07540194000187Male Short Component for Ø6.4mm Assy
07540194000170Male LON Component for Ø5.6mm Assy
07540194000163Male Short Component for Ø5.6mm Assy
07540194000156Male Long Component for Ø5.6mm Assy
07540194000149Male LON Component for Ø4.8mm Assy
07540194000132Male Short Component for Ø4.8mm Assy
07540194000125Male Long Component for Ø4.8mm Assy
07540194000118Male LON Component for Ø4.0mm Assy
07540194000101Male Short Component for Ø4.0mm Assy
07540194000095Male Long Component for Ø4.0mm Assy
07540194000088Male LON Component for Ø3.2mm Assy
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