Peridot-PT Intervertebral body fusion system

GUDID 08800167395948

GBS Commonwealth Co.,Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800167395948
• NIH Device Record Key: aa0c24d8-cb0c-4efe-8096-c2bf5ec564f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peridot-PT Intervertebral body fusion system
• Version Model Number: L531-80C2
• 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	08800167395948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233839

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

Moist Heat or Steam Sterilization

[08800167395948]

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 Intervertebral body fusion system ]

• 08800167328755: L541-F90IS
• 08800167328748: L541-F90GS
• 08800167328731: L541-F90ES
• 08800167328724: L541-D90GS
• 08800167328717: L541-D90ES
• 08800167328700: L541-D90CS
• 08800167328694: L541-D90AS
• 08800167328687: L541-C90ES
• 08800167328670: L541-C90CS
• 08800167328663: L541-C90AS
• 08800167328656: L541-C906S
• 08800167328649: L541-C904S
• 08800167328632: L541-B90CS
• 08800167328625: L541-B90AS
• 08800167328618: L541-B906S
• 08800167328601: L541-B904S
• 08800167328595: L541-B902S
• 08800167328588: L541-890AS
• 08800167328571: L541-8906S
• 08800167328564: L541-8904S
• 08800167328557: L541-8902S
• 08800167328540: L541-8900S
• 08800167328533: L541-F24IS
• 08800167328526: L541-F24GS
• 08800167328519: L541-F24ES
• 08800167328502: L541-F24CS
• 08800167328496: L541-D24ES
• 08800167328489: L541-D24CS
• 08800167328472: L541-D24AS
• 08800167328465: L541-D246S
• 08800167328458: L541-C24CS
• 08800167328441: L541-C24AS
• 08800167328434: L541-C246S
• 08800167328427: L541-C244S
• 08800167328410: L541-B24AS
• 08800167328403: L541-B246S
• 08800167328397: L541-B244S
• 08800167328380: L541-B242S
• 08800167328373: L541-824AS
• 08800167328366: L541-8246S
• 08800167328359: L541-8244S
• 08800167328342: L541-8242S
• 08800167328335: L541-8240S
• 08800167328328: L531-80C5S
• 08800167328311: L531-80C4S
• 08800167328304: L531-80C3S
• 08800167328298: L531-80C2S
• 08800167328281: L531-80C1S
• 08800167328274: L531-80C0S
• 08800167328267: L531-80C9S