Double Crank Spinal Blade 7329-58

GUDID 00840199501397

Double Crank Spinal Blade 1.75" (44mm) Wide, 2.75" (70mm) Deep

KOROS U.S.A., INC.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00840199501397
• NIH Device Record Key: 40664e5c-1873-431b-9c31-d8dd598ebf59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Double Crank Spinal Blade
• Version Model Number: 7329-58
• Catalog Number: 7329-58
• 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
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com

Device Dimensions

• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch
• Width: 1.75 Inch
• Depth: 2.75 Inch

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199501397 [Direct Marking]
GS1	10840199501394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881160

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

[00840199501397]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-22
• Device Publish Date: 2021-06-14

On-Brand Devices [Double Crank Spinal Blade]

• 00840199501397: Double Crank Spinal Blade 1.75" (44mm) Wide, 2.75" (70mm) Deep
• 00840199501380: Double Crank Spinal Blade 1.75" (44mm) Wide, 1.5" (38mm) Deep