Black Belt Extended Retractor System All Titanium 7320-05M

GUDID 00840199501847

Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm long Retractor Rack.

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 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 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: 00840199501847
• NIH Device Record Key: 9328da5e-06ec-4fb5-af27-b9346bb439c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Belt Extended Retractor System All Titanium
• Version Model Number: 7320-05M
• Catalog Number: 7320-05M
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199501847 [Direct Marking]
GS1	10840199501844 [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

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

[00840199501847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

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• 00840199533329 - Dissector: 2024-02-14 Rhoton Type Dissector No. 3
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• 00840199533367 - Dissector: 2024-02-14 Rhoton Type Spatula Dissector No. 7
• 00840199533374 - Dissector: 2024-02-14 Rhoton Type Spatula Dissector No. 8