RTI Allograft Paste

GUDID 00898623002019

Allograft Paste 5cc

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00898623002019
• NIH Device Record Key: f68b6ebe-c63e-4c3a-ad6c-13f39e05fb66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTI Allograft Paste
• Version Model Number: 801205
• 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	00898623002019 [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

On-Brand Devices [RTI Allograft Paste]

• 00898623002125: Allograft Paste 1cc
• 00898623002118: Allograft Paste 0.5cc
• 00898623002101: Allograft Paste 0.2cc
• 00898623002095: Allograft Paste IC 10cc
• 00898623002088: Allograft Paste IC 5cc
• 00898623002071: Allograft Paste IC, RT, 3cc
• 00898623002064: Allograft Paste IC, RT, 2cc
• 00898623002057: Allograft Paste IC, RT, 1cc
• 00898623002040: Allograft Paste IC 10cc
• 00898623002033: Allograft Paste IC 5cc
• 00898623002026: Allograft Paste 10cc
• 00898623002019: Allograft Paste 5cc
• 00898623002002: Allograft Paste 1cc