Black Belt Legend All Titanium Basic Retractor System 7320-00PT

GUDID 00840199504404

Black Belt Legend All Titanium Basic Retractor System, Consists of the Following: 1x 7320-22P - Korpectomy Ti Retractor frame Right 1x 7320-20P - Ti Retractor frame Left 1x 7320-30P - Ti Retractor frame Offset 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40M - Ti Blade Inserting Clamps 2x 7322-34M - Pronged Ti Blade 34mm, 2x 7322-40M - Pronged Ti Blade 40mm, 2x 7322-45M - Pronged Ti Blade 45mm, 2x 7322-50M - Pronged Ti Blade 50mm, 2x 7322-55M - Pronged Ti Blade 55mm, 2x 7322-60M - Pronged Ti Blade 60mm, 2x 7322-70M - Pronged Ti Blade 70mm, 2x 7324-34M - Blunt Ti Blade 34mm, 2x 7324-40M - Blunt Ti Blade 40mm, 2x 7324-45M - Blunt Ti Blade 45mm, 2x 7324-50M - Blunt Ti Blade 50mm, 2x 7324-55M - Blunt Ti Blade 55mm, 2x 7324-60M - Blunt Ti Blade 60mm, 2x 7324-70M - Blunt Ti Blade 70mm, 4x 7326-40M - Two-Level Ti Blade Pronged 40mm, 4x 7326-47M - Two-Level Ti Blade Pronged 47mm, 4x 7326-55M - Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Sterilizing Instrument Case with silicone pads

KOROS U.S.A., INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable

• Primary Device ID: 00840199504404
• NIH Device Record Key: 247fc427-e4cc-47cf-8a0b-ac7d3cd4d780
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Belt Legend All Titanium Basic Retractor System
• Version Model Number: 7320-00PT
• Catalog Number: 7320-00PT
• 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

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	00840199504404 [Direct Marking]
GS1	10840199504401 [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

[00840199504404]

Moist Heat or Steam Sterilization

[00840199504404]

Moist Heat or Steam Sterilization

[00840199504404]

Moist Heat or Steam Sterilization

[00840199504404]

Moist Heat or Steam Sterilization

[00840199504404]

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

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