Excel Black Belt PRO Extended Ti Retractor Set 7320-05PET

GUDID 00840199545810

Excel Black Belt PRO Extended Ti Retractor Set

KOROS U.S.A., INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00840199545810
• NIH Device Record Key: 900a65b8-007c-4084-b527-802df6c6525c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excel Black Belt PRO Extended Ti Retractor Set
• Version Model Number: 7320-05PET
• Catalog Number: 7320-05PET
• 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: true
• 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
• 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
• 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
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com

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
• 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
• 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
• 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	00840199545810 [Direct Marking]
GS1	10840199545817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935529

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

[00840199545810]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

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• 00840199515455 - Drill Guide: 2024-06-10 Cervical Vert Distraction Drill Guide (Right)
• 00840199515462 - Drill Guide: 2024-06-10 Cervical Vert Distraction Drill Guide (Left)
• 00840199515479 - Drill Guide: 2024-06-10 Drill Guide
• 00840199516216 - Nerve Stimulator Probe: 2024-06-10 Nerve Stimulator Dilator Probe 5.5mm
• 00840199517251 - Lamina Spreader: 2024-06-10 Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep
• 00840199517268 - Lamina Spreader: 2024-06-10 Laminia Spread 16mm,7.5cm dp