Agile Instruments 285946

GUDID 00811714036342

Drill (2.0mm), Drill Guide, and 2 Free Needles

RESPONSIVE ORTHOPEDICS LLC

Fluted surgical drill bit, single-use

• Primary Device ID: 00811714036342
• NIH Device Record Key: 9959270d-f352-494b-8ce5-164154b180ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agile Instruments
• Version Model Number: 285946
• Catalog Number: 285946
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00811714036342 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

• 00811714036144 - Superhawk: 2025-05-22 Superhawk 3.75mm/4.75mm Suture Anchors
• 00811714036151 - Superhawk: 2025-05-22 Superhawk 3.75mm End Suture Anchor
• 00811714036168 - Superhawk: 2025-05-22 Superhawk Instrument Tray
• 00811714036199 - Superhawk: 2025-05-22 Superhawk Drill 3.5mm
• 00811714036205 - Superhawk: 2025-05-22 Superhawk Cannulated Drill 3.0mm
• 00811714036212 - Superhawk: 2025-05-22 Superhawk Drill 3.0mm
• 00811714036229 - Superhawk: 2025-05-22 Superhawk Cannulated Drill 3.5mm
• 00811714036236 - Superhawk: 2025-05-22 Superhawk Guidewire 150mm Length