OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-087

GUDID 00841132119167

IM FEMORAL NAIL, 8mm x 36cm, Left

ORTHOPEDIATRICS CORP.

Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 00841132119167
• NIH Device Record Key: ed50b62d-4884-4681-89a8-ea5155a4d2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics PediNail Intramedullary Nailing System
• Version Model Number: 10-1500-087
• Catalog Number: 10-1500-087
• 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	00841132119167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083726

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 2015-09-28

On-Brand Devices [OrthoPediatrics PediNail Intramedullary Nailing System]

• 00841132119341: IM FEMORAL NAIL, 10mm x 42cm, Left
• 00841132119334: IM FEMORAL NAIL, 10mm x 40cm, Left
• 00841132119327: IM FEMORAL NAIL, 10mm x 38cm, Left
• 00841132119310: IM FEMORAL NAIL, 10mm x 36cm, Left
• 00841132119303: IM FEMORAL NAIL, 10mm x 34cm, Left
• 00841132119297: IM FEMORAL NAIL, 10mm x 32cm, Left
• 00841132119280: IM FEMORAL NAIL, 10mm x 30cm, Left
• 00841132119273: IM FEMORAL NAIL, 9mm x 42cm, Left
• 00841132119266: IM FEMORAL NAIL, 9mm x 40cm, Left
• 00841132119259: IM FEMORAL NAIL, 9mm x 38cm, Left
• 00841132119242: IM FEMORAL NAIL, 9mm x 36cm, Left
• 00841132119235: IM FEMORAL NAIL, 9mm x 34cm, Left
• 00841132119228: IM FEMORAL NAIL, 9mm x 32cm, Left
• 00841132119211: IM FEMORAL NAIL, 9mm x 30cm, Left
• 00841132119204: IM FEMORAL NAIL, 9mm x 28cm, Left
• 00841132119198: IM FEMORAL NAIL, 8mm x 42cm, Left
• 00841132119181: IM FEMORAL NAIL, 8mm x 40cm, Left
• 00841132119174: IM FEMORAL NAIL, 8mm x 38cm, Left
• 00841132119167: IM FEMORAL NAIL, 8mm x 36cm, Left
• 00841132119150: IM FEMORAL NAIL, 8mm x 34cm, Left
• 00841132119143: IM FEMORAL NAIL, 8mm x 32cm, Left
• 00841132119136: IM FEMORAL NAIL, 8mm x 30cm, Left
• 00841132119129: IM FEMORAL NAIL, 8mm x 28cm, Left
• 00841132119112: IM FEMORAL NAIL, 8mm x 26cm, Left
• 00841132119105: IM FEMORAL NAIL, 8mm x 24cm, Left
• 00841132119099: IM FEMORAL NAIL, 7mm x 38cm, Left
• 00841132119082: IM FEMORAL NAIL, 7mm x 36cm, Left
• 00841132119075: IM FEMORAL NAIL, 7mm x 34cm, Left
• 00841132119068: IM FEMORAL NAIL, 7mm x 32cm, Left
• 00841132119051: IM FEMORAL NAIL, 7mm x 30cm, Left
• 00841132119044: IM FEMORAL NAIL, 7mm x 28cm, Left
• 00841132119037: IM FEMORAL NAIL, 7mm x 26cm, Left
• 00841132119020: IM FEMORAL NAIL, 7mm x 24cm, Left
• 00841132119013: IM FEMORAL NAIL, 7mm x 22cm, Left
• 00841132119006: IM FEMORAL NAIL, 7mm x 20cm, Left
• 00841132118993: IM FEMORAL NAIL, 7mm x 18cm, Left
• 00841132118986: IM FEMORAL NAIL, 7mm x 16cm, Left
• 00841132118979: IM FEMORAL NAIL, 7mm x 14cm, Left
• 00841132118962: IM FEMORAL NAIL, 7mm x 12cm, Left
• 00841132118955: IM FEMORAL NAIL, 10mm x 42cm, Right
• 00841132118948: IM FEMORAL NAIL, 10mm x 40cm, Right
• 00841132118931: IM FEMORAL NAIL, 10mm x 38cm, Right
• 00841132118924: IM FEMORAL NAIL, 10mm x 36cm, Right
• 00841132118917: IM FEMORAL NAIL, 10mm x 34cm, Right
• 00841132118900: IM FEMORAL NAIL, 10mm x 32cm, Right
• 00841132118894: IM FEMORAL NAIL, 10mm x 30cm, Right
• 00841132118887: IM FEMORAL NAIL, 9mm x 42cm, Right
• 00841132118870: IM FEMORAL NAIL, 9mm x 40cm, Right
• 00841132118863: IM FEMORAL NAIL, 9mm x 38cm, Right
• 00841132118856: IM FEMORAL NAIL, 9mm x 36cm, Right