Avatar 2019-0040

GUDID 00190837033668

Static Tube, 7cm X 14mm

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837033668
• NIH Device Record Key: 36f380d8-7938-4494-b719-dfe44f3f191d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avatar
• Version Model Number: 2019-0040
• Catalog Number: 2019-0040
• 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	00190837033668 [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

[00190837033668]

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]

• 00190837098216: Static Tube, 8cm X 12mm
• 00190837098209: Static Tube, 6cm X 12mm
• 00190837098193: Static Tube, 4cm X 12mm
• 00190837098186: Static Tube, 8cm X 10mm
• 00190837098179: Static Tube, 6cm X 10mm
• 00190837098162: Static Tube, 4cm X 10mm
• 00190837098155: Static Tube, 8cm X 8mm
• 00190837098148: Static Tube, 6cm X 8mm
• 00190837098131: Static Tube, 4cm X 8mm
• 00190837089313: Rescue Tower Guide
• 00190837089306: Rescue Tower
• 00190837089290: Cannulated Scalpel Handle
• 00190837089283: Extension Tab Remover
• 00190837089276: Blunt Dissector
• 00190837089269: MIS Awl
• 00190837089252: Detachable CT Handle
• 00190837034603: T30 Locking Cap Removal Driver
• 00190837033743: Static Tube, 7cm X 18mm
• 00190837033736: Static Tube, 6cm X 18mm
• 00190837033729: Static Tube, 5cm X 18mm
• 00190837033712: Static Tube, 4cm X 18mm
• 00190837033705: Static Tube, 7cm X 16mm
• 00190837033699: Static Tube, 6cm X 16mm
• 00190837033682: Static Tube, 5cm X 16mm
• 00190837033675: Static Tube, 4cm X 16mm
• 00190837033668: Static Tube, 7cm X 14mm
• 00190837033651: Static Tube, 6cm X 14mm
• 00190837033644: Static Tube, 5cm X 14mm
• 00190837033637: Static Tube, 4cm X 14mm
• 00190837033545: Static Tube, 4cm X 16mm
• 00190837033538: Static Tube, 7cm X 14mm
• 00190837033521: Static Tube, 6cm X 14mm
• 00190837033514: Static Tube, 5cm X 14mm