PediNail 00-1500-5072

GUDID 00841132129265

5.0MM LOCKING BOLT, 72MM

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132129265
• NIH Device Record Key: 28b540e2-1f7a-48d3-9e3b-a5ead7876e44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediNail
• Version Model Number: 00-1500-5072
• Catalog Number: 00-1500-5072
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132129265 [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: 2016-10-31

On-Brand Devices [PediNail]

• 00841132136089: PEDINAIL SCREW CADDY LID
• 00841132136072: PEDINAIL SCREW CADDY
• 00841132135396: SLAP HAMMER CAP
• 00841132135389: SLAP HAMMER ROD
• 00841132135372: SLAP HAMMER HANDLE
• 00841132135365: MODULAR RETAINING BOLT
• 00841132135358: SLAP HAMMER ROD
• 00841132135341: A/O QUICK CONNECT END
• 00841132135334: SLAP HAMMER HANDLE
• 00841132135327: INNER MEASURING DEVICE
• 00841132135310: OUTER MEASURING ROD
• 00841132135303: 12.0 TISSUE PROTECTOR TUBE
• 00841132135297: 10.0 TISSUE PROTECTOR TUBE
• 00841132135280: 7.0 TISSUE PROTECTOR TUBE
• 00841132135273: GUIDE WIRE/EXCHANGE TUBE BOX
• 00841132135167: SCREW CADDY LID
• 00841132135150: SCREW CADDY
• 00841132135143: PEDINAIL SCREW CADDY (IMPLANT & SCREW CADDY)
• 00841132135136: INSTRUMENT INNER TRAY #1
• 00841132135129: INSTRUMENT TRAY #1
• 00841132135112: PEDINAIL INSTRUMENT #1 SET (INSTRUMENT & CASE)
• 00841132135105: INSTRUMENT TRAY #2
• 00841132135099: PEDINAIL INSTRUMENT #2 SET (INSTRUMENT & CASE)
• 00841132135082: 3.75MM CALIBRATED DRILL BIT
• 00841132135075: PEDINAIL X-RAY TEMPLATE PACKAGE LABEL
• 00841132135068: PEDINAIL XL IMPLANT TRAY RIGHT
• 00841132135051: PEDINAIL XL IMPLANT BASE RIGHT
• 00841132135044: PEDINAIL XL IMPLANT TRAY LEFT
• 00841132135037: PEDINAIL XL IMPLANT BASE LEFT
• 00841132135020: PEDINAIL XL RIGHT IMPLANT SET
• 00841132135013: PEDINAIL XL LEFT IMPLANT SET
• 00841132135006: PEDINAIL SCREW CADDY
• 00841132134993: PEDINAIL IMPLANT INNER TRAY - RIGHT
• 00841132134986: PEDINAIL IMPLANT TRAY - RIGHT
• 00841132134979: PEDINAIL RIGHT IMPLANT SET (RIGHT IMPLANT & CASE)
• 00841132134962: PEDINAIL LEFT IMPLANT SET (LEFT IMPLANT & CASE)
• 00841132134955: PEDINAIL IMPLANT INNER TRAY - LEFT
• 00841132134948: PEDINAIL IMPLANT TRAY - LEFT
• 00841132134931: PEDINAIL INSTRUMENT INNER TRAY #1
• 00841132134924: PEDINAIL INSTRUMENT TRAY #1
• 00841132134917: PEDINAIL CASE LID
• 00841132134900: PEDINAIL INSTRUMENT TRAY #2
• 00841132129456: HEADLESS LOCKING BOLT, 60MM
• 00841132129449: HEADLESS LOCKING BOLT, 32MM
• 00841132129432: HEADLESS LOCKING BOLT, 30MM
• 00841132129425: 5.0MM LOCKING BOLT, 98MM
• 00841132129418: 5.0MM LOCKING BOLT, 96MM
• 00841132129401: 5.0MM LOCKING BOLT, 95MM
• 00841132129395: 5.0MM LOCKING BOLT, 94MM
• 00841132129388: 5.0MM LOCKING BOLT, 92MM