Spirit PEEK

GUDID 00811714035383

Spirit PEEK Guide Wire Standard

RESPONSIVE ORTHOPEDICS LLC

Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool

• Primary Device ID: 00811714035383
• NIH Device Record Key: 0a182eb7-92fa-4441-8412-db2eea330843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirit PEEK
• Version Model Number: 900003-0000
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• 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: true
• 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	00811714035383 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

[00811714035383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [Spirit PEEK]

• 00811714035383: Spirit PEEK Guide Wire Standard
• 00811714034638: Spirit PEEK Screwdriver
• 00811714032627: Spirit PEEK Tap 12mm
• 00811714032610: Spirit PEEK Tap 11mm
• 00811714032603: Spirit PEEK Tap 10mm
• 00811714032597: Spirit PEEK Tap 9mm
• 00811714032580: Spirit PEEK Tap 8mm
• 00811714032573: Spirit PEEK Tap 7mm
• 00811714032658: Spirit PEEK Instrument Set