Lightning Short Instruments 905011-0000

GUDID 00811714035765

Drill and Drill Guide

RESPONSIVE ORTHOPEDICS LLC

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• Primary Device ID: 00811714035765
• NIH Device Record Key: 7d98852a-cebe-4c79-9a79-7c2631307e03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning Short Instruments
• Version Model Number: 905011-0000
• Catalog Number: 905011-0000
• 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: 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	00811714035765 [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: 2023-08-03
• Device Publish Date: 2023-07-26

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