OrthoPediatrics PediFlex Flexible Nail System 00-1000-320

GUDID 00841132119495

ø2.0mm x 300mm Flexible IM Nail

ORTHOPEDIATRICS CORP.

Femur nail, sterile

• Primary Device ID: 00841132119495
• NIH Device Record Key: 71b9a6c1-c6ee-47f7-8f83-4d59221e79a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics PediFlex Flexible Nail System
• Version Model Number: 00-1000-320
• Catalog Number: 00-1000-320
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132119495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081097

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

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