OrthoPediatrics PediFlex Flexible Nail System 00-1000-020

GUDID 00841132100059

Ø2.0 MM X 300 MM FLEXIBLE IM NAIL

ORTHOPEDIATRICS CORP.

Femur nail

• Primary Device ID: 00841132100059
• NIH Device Record Key: 146ddb5e-a411-4b66-bf2f-05685db669ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics PediFlex Flexible Nail System
• Version Model Number: 00-1000-020
• Catalog Number: 00-1000-020
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132100059 [Primary]

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

[00841132100059]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [OrthoPediatrics PediFlex Flexible Nail System]

• 00841132119655: ø4.5mm x 450mm Round Tip Flexible IM Nail
• 00841132119648: ø4.0mm x 450mm Round Tip Flexible IM Nail
• 00841132119631: ø3.5mm x 400mm Round Tip Flexible IM Nail
• 00841132119624: ø3.0mm x 400mm Round Tip Flexible IM Nail
• 00841132119617: ø2.5mm x 300mm Round Tip Flexible IM Nail
• 00841132119600: ø2.0mm x 300mm Round Tip Flexible IM Nail
• 00841132119594: ø1.5mm x 300mm Round Tip Flexible IM Nail
• 00841132119525: ø3.5mm x 400mm Flexible IM Nail
• 00841132119518: ø3.0mm x 400mm Flexible IM Nail
• 00841132119501: ø2.5mm x 300mm Flexible IM Nail
• 00841132119495: ø2.0mm x 300mm Flexible IM Nail
• 00841132119488: ø1.5mm x 300mm Flexible IM Nail
• 00841132119471: ø4.5mm Flexible IM Nail Cap (2 Each)
• 00841132119464: ø4.0mm Flexible IM Nail Cap (2 Each)
• 00841132119457: ø3.5mm Flexible IM Nail Cap (2 Each)
• 00841132119440: ø3.0mm Flexible IM Nail Cap (2 Each)
• 00841132119433: ø2.5mm Flexible IM Nail Cap (2 Each)
• 00841132119426: ø2.0mm Flexible IM Nail Cap (2 Each)
• 00841132119419: ø1.5mm Flexible IM Nail Cap (2 Each)
• 00841132119402: ø4.5mm x 450mm Flexible IM Nail
• 00841132119396: ø4.0mm x 450mm Flexible IM Nail
• 00841132119389: ø3.5mm x 400mm Flexible IM Nail
• 00841132119372: ø3.0mm x 400mm Flexible IM Nail
• 00841132119365: ø2.5mm x 300mm Flexible IM Nail
• 00841132119358: ø1.5mm x 300mm Flexible IM Nail
• 00841132100059: Ø2.0 MM X 300 MM FLEXIBLE IM NAIL