Stealth 911002-0002

GUDID 00811714035697

Stealth Castle Guide Tube

RESPONSIVE ORTHOPEDICS LLC

Surgical drill guide, reusable

• Primary Device ID: 00811714035697
• NIH Device Record Key: a7325459-1408-456d-a4a7-816305cc2637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth
• Version Model Number: 911002-0002
• Catalog Number: 911002-0002
• 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: 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	00811714035697 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

[00811714035697]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Stealth]

• 00811714035871: Stealth Instruments
• 00811714035741: Stealth Instrument Tray
• 00811714035734: Stealth Blunt Probe
• 00811714035710: Stealth Probe
• 00811714035697: Stealth Castle Guide Tube
• 00811714035673: Stealth Drill 3.2mm
• 00811714035970: Stealth Soft Bone Drill 3.0mm
• 00811714036038: Stealth Blunt Probe
• 00811714036021: Stealth Probe
• 00811714036014: Stealth Soft Bone Drill 3.0mm
• 00811714036007: Stealth Castle Guide Tube
• 00811714035994: Stealth Drill 3.0mm