PRASE-C Anterior Cervical Plate System

GUDID 08800113311596

GBS Commonwealth Co.,Ltd.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800113311596
• NIH Device Record Key: 96836e6b-3264-4739-a593-d3c6bd22541f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRASE-C Anterior Cervical Plate System
• Version Model Number: C122-3722
• 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	08800113311596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202878

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

[08800113311596]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-28

On-Brand Devices [PRASE-C Anterior Cervical Plate System]

• 08800113313842: C128-4226
• 08800113313835: C128-4225
• 08800113313828: C128-4224
• 08800113313811: C128-4223
• 08800113313804: C128-4222
• 08800113313798: C128-4221
• 08800113313781: C128-4220
• 08800113313774: C128-4219
• 08800113313767: C128-4218
• 08800113313750: C128-4217
• 08800113313743: C128-4216
• 08800113313736: C128-4215
• 08800113313729: C128-4214
• 08800113313712: C128-4213
• 08800113313705: C128-4212
• 08800113313699: C128-4211
• 08800113313682: C128-4210
• 08800113313675: C128-3726
• 08800113313668: C128-3725
• 08800113313651: C128-3724
• 08800113313644: C128-3723
• 08800113313637: C128-3722
• 08800113313620: C128-3721
• 08800113313613: C128-3720
• 08800113313606: C128-3719
• 08800113313590: C128-3718
• 08800113313583: C128-3717
• 08800113313576: C128-3716
• 08800113313569: C128-3715
• 08800113313552: C128-3714
• 08800113313545: C128-3713
• 08800113313538: C128-3712
• 08800113313521: C128-3711
• 08800113313514: C128-3710
• 08800113313507: C127-4226
• 08800113313491: C127-4225
• 08800113313484: C127-4224
• 08800113313477: C127-4223
• 08800113313460: C127-4222
• 08800113313453: C127-4221
• 08800113313446: C127-4220
• 08800113313439: C127-4219
• 08800113313422: C127-4218
• 08800113313415: C127-4217
• 08800113313408: C127-4216
• 08800113313392: C127-4215
• 08800113313385: C127-4214
• 08800113313378: C127-4213
• 08800113313361: C127-4212
• 08800113313354: C127-4211