Thunderbolt

GUDID 00811714035956

Thunderbolt Tensioner Lower - Packaged

RESPONSIVE ORTHOPEDICS LLC

Suture/ligature tightener, reusable

• Primary Device ID: 00811714035956
• NIH Device Record Key: 635a2341-6f9b-4173-a458-7e9b8899ba0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thunderbolt
• Version Model Number: 909004-0000-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	00811714035956 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

[00811714035956]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Thunderbolt]

• 00811714035055: Thunderbolt Screw Driver
• 00811714035048: Thunderbolt Drill Guide
• 00811714035017: Thunderbolt Tensioner Upper Assembly
• 00811714035000: Thunderbolt Tensioner Middle
• 00811714034997: Thunderbolt Tensioner Lower
• 00811714034966: Thunderbolt Guide Wire Long
• 00811714034942: Thunderbolt Drill Guide Insert
• 00811714034928: Thunderbolt Button Drill
• 00811714034911: Thunderbolt Button Drill Cannulated
• 00811714035338: Thunderbolt Instrument Set
• 00811714035659: Thunderbolt Button Drill
• 00811714035956: Thunderbolt Tensioner Lower - Packaged
• 00811714036090: Thunderbolt Button Drill Cannulated
• 00811714036083: Thunderbolt Guide Wire Long