Super-Slide Wide Blade w/teeth 7329-436

GUDID 00840199504411

Super-Slide Wide Blade w/teeth 2 x 3 1/8"

KOROS U.S.A., INC.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00840199504411
• NIH Device Record Key: 5dfe2908-dfcd-4f38-b628-c2f2f47cb5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super-Slide Wide Blade w/teeth
• Version Model Number: 7329-436
• Catalog Number: 7329-436
• 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

Device Dimensions

• Width: 2.5 Inch
• Depth: 5.5 Inch
• Width: 2.5 Inch
• Depth: 5.5 Inch
• Width: 2.5 Inch
• Depth: 5.5 Inch
• Width: 2.5 Inch
• Depth: 5.5 Inch
• Width: 2.5 Inch
• Depth: 5.5 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199504411 [Direct Marking]
GS1	10840199504418 [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

[00840199504411]

Moist Heat or Steam Sterilization

[00840199504411]

Moist Heat or Steam Sterilization

[00840199504411]

Moist Heat or Steam Sterilization

[00840199504411]

Moist Heat or Steam Sterilization

[00840199504411]

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

On-Brand Devices [Super-Slide Wide Blade w/teeth]

• 00840199501144: Super-Slide Wide Blade w/teeth 2 1/2 x 5 1/2"
• 00840199501137: Super-Slide Wide Blade w/teeth 1 3/4 x 4 3/4"
• 00840199501120: Super-Slide Wide Blade w/teeth 2 x 4 1/8"
• 00840199504411: Super-Slide Wide Blade w/teeth 2 x 3 1/8"