Sentry ALIF 2019-0081

GUDID 00190837091514

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837091514
• NIH Device Record Key: eae37fb9-0dde-4024-b6d6-b0bd762fd7dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentry ALIF
• Version Model Number: 2019-0081
• Catalog Number: 2019-0081
• 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	00190837091514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132589

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

Moist Heat or Steam Sterilization

[00190837091514]

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 [Sentry ALIF]

• 00190837021481: 169-050-46
• 00190837021474: 169-050-44
• 00190837021467: 169-050-42
• 00190837021450: 169-050-40
• 00190837021443: 169-050-38
• 00190837021436: 169-050-36
• 00190837021429: 169-050-34
• 00190837021412: 169-050-32
• 00190837021405: 169-765-40
• 00190837021399: 169-765-35
• 00190837021382: 169-765-30
• 00190837021375: 169-765-25
• 00190837021368: 169-765-20
• 00190837021351: 169-755-40
• 00190837021344: 169-755-35
• 00190837021337: 169-755-30
• 00190837021320: 169-755-25
• 00190837021313: 169-755-20
• 00190837021306: 169-100-46
• 00190837021290: 169-100-44
• 00190837021283: 169-100-42
• 00190837021276: 169-100-40
• 00190837021269: 169-100-38
• 00190837021252: 169-100-36
• 00190837021245: 169-100-34
• 00190837021238: 169-100-32
• 00190837091521: 2019-0082
• 00190837091514: 2019-0081