Spirit Titanium

GUDID 00811714035390

Spirit Titanium Guide Wire Standard

RESPONSIVE ORTHOPEDICS LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00811714035390
• NIH Device Record Key: e9d932e0-387d-415b-a3df-e3c1d1a63353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirit Titanium
• Version Model Number: 901003-0000
• 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	00811714035390 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

Moist Heat or Steam Sterilization

[00811714035390]

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 Titanium]

• 00811714035390: Spirit Titanium Guide Wire Standard
• 00811714034461: Spirit Titanium Screwdriver
• 00811714032566: Spirit Titanium Tap 10mm
• 00811714032559: Spirit Titanium Tap 9mm
• 00811714032542: Spirit Titanium Tap 8mm
• 00811714032535: Spirit Titanium Tap 7mm
• 00811714032665: Spirit Titanium Instrument Set