Avatar Instruments 2019-0036

GUDID 00190837033477

MIS 6.5mm DAT

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837033477
• NIH Device Record Key: 7d886111-163f-47f9-b04c-e0a52ee9a595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avatar Instruments
• Version Model Number: 2019-0036
• Catalog Number: 2019-0036
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837033477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837033477]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Avatar Instruments]

• 00190837033477: MIS 6.5mm DAT
• 00190837033460: MIS 5.5mm DAT