Eagle 000617-0000-P01

GUDID 00811714035987

Eagle Drill Guide - Packaged

RESPONSIVE ORTHOPEDICS LLC

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable 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

• 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
• 00811714036045 - Mini Stealth: 2024-04-09 Mini Stealth Drill 2.1mm
• 00811714036052 - Mini Stealth: 2024-04-09 Mini Stealth Castle Guide Tube
• 00811714036069 - Mini Stealth: 2024-04-09 Mini Stealth Probe