COMET Lumbar Interbody Fusion Cage

GUDID 04710577041509

PEEK Interbody Fusion Cage

BAUI BIOTECH CO. LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 04710577041509
• NIH Device Record Key: 18cbfce5-79d4-434b-ab87-2325a582e7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMET Lumbar Interbody Fusion Cage
• Version Model Number: 595-13318
• Company DUNS: 656775504
• Company Name: BAUI BIOTECH CO. LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710577041509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191353

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [COMET Lumbar Interbody Fusion Cage]

• 04718005151950: PEEK Interbody Fusion Cage
• 04718005151943: PEEK Interbody Fusion Cage
• 04718005152414: PEEK Interbody Fusion Cage
• 04718005152407: PEEK Interbody Fusion Cage
• 04718005152391: PEEK Interbody Fusion Cage
• 04718005152384: PEEK Interbody Fusion Cage
• 04718005152377: PEEK Interbody Fusion Cage
• 04718005152360: PEEK Interbody Fusion Cage
• 04718005152353: PEEK Interbody Fusion Cage
• 04718005152346: PEEK Interbody Fusion Cage
• 04718005152339: PEEK Interbody Fusion Cage
• 04718005152322: PEEK Interbody Fusion Cage
• 04718005152315: PEEK Interbody Fusion Cage
• 04718005152308: PEEK Interbody Fusion Cage
• 04718005152292: PEEK Interbody Fusion Cage
• 04718005152285: PEEK Interbody Fusion Cage
• 04718005152278: PEEK Interbody Fusion Cage
• 04718005152261: PEEK Interbody Fusion Cage
• 04718005152254: PEEK Interbody Fusion Cage
• 04718005152247: PEEK Interbody Fusion Cage
• 04718005152230: PEEK Interbody Fusion Cage
• 04718005152223: PEEK Interbody Fusion Cage
• 04718005152216: PEEK Interbody Fusion Cage
• 04718005152209: PEEK Interbody Fusion Cage
• 04718005152193: PEEK Interbody Fusion Cage
• 04718005152186: PEEK Interbody Fusion Cage
• 04718005152179: PEEK Interbody Fusion Cage
• 04718005152162: PEEK Interbody Fusion Cage
• 04718005152155: PEEK Interbody Fusion Cage
• 04718005152148: PEEK Interbody Fusion Cage
• 04718005152131: PEEK Interbody Fusion Cage
• 04718005152124: PEEK Interbody Fusion Cage
• 04718005152117: PEEK Interbody Fusion Cage
• 04718005152100: PEEK Interbody Fusion Cage
• 04718005152094: PEEK Interbody Fusion Cage
• 04718005152087: PEEK Interbody Fusion Cage
• 04718005152070: PEEK Interbody Fusion Cage
• 04718005152063: PEEK Interbody Fusion Cage
• 04718005152056: PEEK Interbody Fusion Cage
• 04718005152049: PEEK Interbody Fusion Cage
• 04718005152032: PEEK Interbody Fusion Cage
• 04718005152025: PEEK Interbody Fusion Cage
• 04718005152018: PEEK Interbody Fusion Cage
• 04718005152001: PEEK Interbody Fusion Cage
• 04718005151998: PEEK Interbody Fusion Cage
• 04718005151981: PEEK Interbody Fusion Cage
• 04718005151974: PEEK Interbody Fusion Cage
• 04718005151967: PEEK Interbody Fusion Cage
• 04710577041554: PEEK Interbody Fusion Cage
• 04710577041547: PEEK Interbody Fusion Cage