Kestrel® LS-434

GUDID M711LS4340

SST, Al, Silicone

Innovasis, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M711LS4340
• NIH Device Record Key: e1dcf4a4-59a8-451d-95f1-729d05fde077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kestrel®
• Version Model Number: LS-434
• Catalog Number: LS-434
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 801-261-2236
• Email: info@innovasis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS4340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181063

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M711LS4340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-30

On-Brand Devices [Kestrel®]

• M711LS4340: SST, Al, Silicone
• M711BTA1580: Polypropylene, Radel
• M711BTA1570: Al, SST, Nylon, Silicone
• M711UT65200: Ti 6Al 4V (ELI)
• M711UT55300: Ti 6Al 4V (ELI)
• M711UT55250: Ti 6Al 4V (ELI)
• M711UT55200: Ti 6Al 4V (ELI)
• M711LS4350: SST
• M711UT280: Ti 6Al 4V (ELI)
• M711UT240: Ti 6Al 4V (ELI)
• M711UT200: Ti 6Al 4V (ELI)