Black Belt Blunt Ti Blade 7324-45M

GUDID 00840199503162

Black Belt Blunt Titanium Blade 22 x 45mm

KOROS U.S.A., INC.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00840199503162
• NIH Device Record Key: 7cc862a4-f21b-4a3e-bd92-7532be1af021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Belt Blunt Ti Blade
• Version Model Number: 7324-45M
• Catalog Number: 7324-45M
• 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
• 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

Device Dimensions

• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter
• Width: 22 Millimeter
• Depth: 45 Millimeter

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	00840199503162 [Direct Marking]
GS1	10840199503169 [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

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

[00840199503162]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-10
• Device Publish Date: 2021-06-02

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• 00840199503223: Black Belt Blunt Titanium Blade 22 x 50mm
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• 00840199503131: Black Belt Blunt Titanium Blade 22 x 40mm
• 00840199503124: Black Belt Blunt Titanium Blade 22 x 40mm
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• 00840199503308: Black Belt Blunt Titanium Blade 22 x 60mm
• 00840199503292: Black Belt Blunt Titanium Blade 22 x 60mm
• 00840199503285: Black Belt Blunt Titanium Blade 22 x 60mm
• 00840199503919: Black Belt Blunt Titanium Blade 22 x 95mm
• 00840199503902: Black Belt Blunt Titanium Blade 22 x 110mm
• 00840199503896: Black Belt Blunt Titanium Blade 22 x 100mm
• 00840199545445: Black Belt Blunt Titanium Blade 22 x 75mm
• 00840199545346: Black Belt Blunt Titanium Blade 22 x 115mm
• 00840199545292: Black Belt Blunt Titanium Blade 22 x 120mm
• 00840199545285: Black Belt Blunt Titanium Blade 22 x 105mm
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