Eagle 000617-0000-P01

GUDID 00811714035987

Eagle Drill Guide - Packaged

RESPONSIVE ORTHOPEDICS LLC

Surgical drill guide, reusable

• Primary Device ID: 00811714035987
• NIH Device Record Key: 42df12f9-f6fa-4863-b9f5-61bc9fa36b1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eagle
• Version Model Number: 000617-0000-P01
• Catalog Number: 000617-0000-P01
• 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	00811714035987 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

[00811714035987]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

• 00811714036106 - Lightning Long: 2024-05-28 Lightning Guide Tube Castle Long
• 00811714036113 - Lightning Long: 2024-05-28 Lightning Long V-Mouth Guide Tube
• 00811714036120 - Lightning: 2024-05-28 Lightning Blunt Probe
• 00811714035994 - Stealth: 2024-04-09 Stealth Drill 3.0mm
• 00811714036007 - Stealth: 2024-04-09 Stealth Castle Guide Tube
• 00811714036014 - Stealth: 2024-04-09 Stealth Soft Bone Drill 3.0mm
• 00811714036021 - Stealth: 2024-04-09 Stealth Probe
• 00811714036038 - Stealth: 2024-04-09 Stealth Blunt Probe