FASSIER-DUVAL TELESCOPIC IM SYSTEM M048-SS-LON-S

GUDID 07540194013361

STERILE MALE LON COMPONENT FOR Ø4.8mm ASSY

Pega Medical Inc

Femur nail, sterile

• Primary Device ID: 07540194013361
• NIH Device Record Key: af81d514-4337-40f9-a031-8c2598fab62b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Version Model Number: M048-SS-LON-S
• Catalog Number: M048-SS-LON-S
• Company DUNS: 257315713
• Company Name: Pega Medical Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com

Device Dimensions

• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter
• Outer Diameter: 4.8 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540194013361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211292

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

[07540194013361]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [FASSIER-DUVAL TELESCOPIC IM SYSTEM]

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