Cervical Graft Driver 7222-40

GUDID 00840199500338

Cervical Graft Driver Unguarded 7x12mm

KOROS U.S.A., INC.

External spinal fixation system

• Primary Device ID: 00840199500338
• NIH Device Record Key: f70d31ee-12c1-46d5-94ec-1d7205b04b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Graft Driver
• Version Model Number: 7222-40
• Catalog Number: 7222-40
• Company DUNS: 007928633
• Company Name: KOROS U.S.A., 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199500338 [Direct Marking]
GS1	10840199500335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875290

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840199500338]

Moist Heat or Steam Sterilization

[00840199500338]

Moist Heat or Steam Sterilization

[00840199500338]

Moist Heat or Steam Sterilization

[00840199500338]

Moist Heat or Steam Sterilization

[00840199500338]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [Cervical Graft Driver]

• 10840199500359: Cervical Graft Driver Unguarded
• 10840199500342: Cervical Graft Driver Guarded
• 00840199500321: Cervical Graft Driver Guarded 7x12mm
• 00840199500338: Cervical Graft Driver Unguarded 7x12mm