OPTEFIL® Allograft Paste, 5cc 616-01-05

GUDID 10885862094391

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 10885862094391
• NIH Device Record Key: 0ef1785a-4344-4507-86e5-04f01889e2eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTEFIL® Allograft Paste, 5cc
• Version Model Number: 005005
• Catalog Number: 616-01-05
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862094391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043420

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-11-06

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