Peridot-PT Anterior Cervical Intervertebral body fusion system

GUDID 08800167334916

GBS Commonwealth Co.,Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800167334916
• NIH Device Record Key: 98bdbb9c-4c73-4c7b-ad8d-559e15105a4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peridot-PT Anterior Cervical Intervertebral body fusion system
• Version Model Number: C417-2005
• Company DUNS: 694609156
• Company Name: GBS Commonwealth 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: false
• 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	08800167334916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233839

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

[08800167334916]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-29
• Device Publish Date: 2024-01-19

On-Brand Devices [Peridot-PT Anterior Cervical Intervertebral body fusion system ]

• 08800167324771: C41C-1105S
• 08800167324764: C41C-1106S
• 08800167324757: C41C-1107S
• 08800167324740: C41C-1108S
• 08800167324733: C41C-1109S
• 08800167324726: C41C-1110S
• 08800167324719: C41C-1111S
• 08800167324702: C41C-1112S
• 08800167324696: C41C-1113S
• 08800167324689: C41C-1114S
• 08800167324672: C41C-1115S
• 08800167324665: C41C-1405S
• 08800167324658: C41C-1406S
• 08800167324641: C41C-1407S
• 08800167324634: C41C-1408S
• 08800167324627: C41C-1409S
• 08800167324610: C41C-1410S
• 08800167324603: C41C-1411S
• 08800167324597: C41C-1412S
• 08800167324580: C41C-1413S
• 08800167324573: C41C-1414S
• 08800167324566: C41C-1415S
• 08800167324559: C41C-1705S
• 08800167324542: C41C-1706S
• 08800167324535: C41C-1707S
• 08800167324528: C41C-1708S
• 08800167324511: C41C-1709S
• 08800167324504: C41C-1710S
• 08800167324498: C41C-1711S
• 08800167324481: C41C-1712S
• 08800167324474: C41C-1713S
• 08800167324467: C41C-1714S
• 08800167324450: C41C-1715S
• 08800167324443: C41C-2005S
• 08800167324436: C41C-2006S
• 08800167324429: C41C-2007S
• 08800167324412: C41C-2008S
• 08800167324405: C41C-2009S
• 08800167324399: C41C-2010S
• 08800167324382: C41C-2011S
• 08800167324375: C41C-2012S
• 08800167324368: C41C-2013S
• 08800167324351: C41C-2014S
• 08800167324344: C41C-2015S
• 08800167324337: C410-1105S
• 08800167324320: C410-1106S
• 08800167324313: C410-1107S
• 08800167324306: C410-1108S
• 08800167324290: C410-1109S
• 08800167324283: C410-1110S