PNP TIBIA 01-1540-6500

GUDID 00840194467124

6.5mm MONOBLOC NITINOL REAMER, 435mm

ORTHOPEDIATRICS CORP.

Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 00840194467124
• NIH Device Record Key: b290fa8a-af03-4fc4-ad66-f0130d01a295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNP TIBIA
• Version Model Number: 01-1540-6500
• Catalog Number: 01-1540-6500
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00840194467124 [Primary]

FDA Product Code

• KIJ: Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Sterilization

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

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

[00840194467124]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-19
• Device Publish Date: 2024-09-11

On-Brand Devices [PNP TIBIA]

• 00840194466875: FLEXIBLE IM REAMER SHAFT 25IN
• 00840194466585: Large Head Pusher
• 00840194467162: 7.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467155: 6.5mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467148: 6.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467131: 7.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467124: 6.5mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467117: 6.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467100: NITINOL FLEX SHAFT, 635mm
• 00840194467094: NITINOL FLEX SHAFT, 435mm
• 00840194493895: 3.2mm x 330mm K-Wire, Threaded, 316L
• 00840194478366: PNP Tibia 12mm x 500mm Nail
• 00840194478359: PNP Tibia 12mm x 495mm Nail
• 00840194478342: PNP Tibia 12mm x 490mm Nail
• 00840194478335: PNP Tibia 12mm x 485mm Nail
• 00840194478328: PNP Tibia 12mm x 480mm Nail
• 00840194478311: PNP Tibia 12mm x 475mm Nail
• 00840194478304: PNP Tibia 12mm x 470mm Nail
• 00840194478298: PNP Tibia 12mm x 465mm Nail
• 00840194478281: PNP Tibia 12mm x 460mm Nail
• 00840194478274: PNP Tibia 12mm x 455mm Nail
• 00840194478267: PNP Tibia 12mm x 450mm Nail
• 00840194478250: PNP Tibia 12mm x 445mm Nail
• 00840194478243: PNP Tibia 12mm x 440mm Nail
• 00840194478236: PNP Tibia 12mm x 435mm Nail
• 00840194478229: PNP Tibia 12mm x 430mm Nail
• 00840194478212: PNP Tibia 12mm x 425mm Nail
• 00840194478205: PNP Tibia 12mm x 420mm Nail
• 00840194478199: PNP Tibia 12mm x 415mm Nail
• 00840194478182: PNP Tibia 12mm x 410mm Nail
• 00840194478175: PNP Tibia 12mm x 405mm Nail
• 00840194478168: PNP Tibia 12mm x 400mm Nail
• 00840194478151: PNP Tibia 12mm x 395mm Nail
• 00840194478144: PNP Tibia 12mm x 390mm Nail
• 00840194478137: PNP Tibia 12mm x 385mm Nail
• 00840194478120: PNP Tibia 12mm x 380mm Nail
• 00840194478113: PNP Tibia 12mm x 375mm Nail
• 00840194478106: PNP Tibia 12mm x 370mm Nail
• 00840194478090: PNP Tibia 12mm x 365mm Nail
• 00840194478083: PNP Tibia 12mm x 360mm Nail
• 00840194478076: PNP Tibia 12mm x 355mm Nail
• 00840194478069: PNP Tibia 12mm x 350mm Nail
• 00840194478052: PNP Tibia 12mm x 345mm Nail
• 00840194478045: PNP Tibia 12mm x 340mm Nail
• 00840194478038: PNP Tibia 12mm x 335mm Nail
• 00840194478021: PNP Tibia 12mm x 330mm Nail
• 00840194478014: PNP Tibia 12mm x 325mm Nail
• 00840194478007: PNP Tibia 12mm x 320mm Nail
• 00840194477994: PNP Tibia 12mm x 315mm Nail
• 00840194477987: PNP Tibia 12mm x 310mm Nail