Large Dilator Tube

GUDID 10840199500045

Disposable Large Dilator Tube 16mm

KOROS U.S.A., INC.

Nerve-locating system probe, single-use

• Primary Device ID: 10840199500045
• NIH Device Record Key: e2586c09-3c28-4a3c-a643-027e182c10cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Dilator Tube
• Version Model Number: 7332-76D
• Company DUNS: 007928633
• Company Name: KOROS U.S.A., INC.
• Device Count: 1
• DM Exempt: true
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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	10840199500045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120590

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

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

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

[10840199500045]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-08
• Device Publish Date: 2022-01-31

Devices Manufactured by KOROS U.S.A., INC.

• 00840199507726 - Separator: 2025-01-08 Hoen Dura Separator 45 Degree 15cm 6" Length
• 00840199507733 - Separator: 2025-01-08 Hoen Dura Separator 45 Degree 14mm Tip 21cm Length
• 00840199507740 - Elevator: 2025-01-08 Delicate Cottle-Type Elevator 45 Degree 4mm x 6mm Tip 22cm 8-3/4" Lenth
• 00840199507757 - Elevator: 2025-01-08 Adson Periosteal Elevator Chisel Edge 17cm
• 00840199507764 - Elevator: 2025-01-08 Adson Periosteal Elevator Curved Blunt 17cm
• 00840199507771 - Elevator: 2025-01-08 Adson Periosteal Elevator Straight Semi-Sharp 17cm
• 00840199507788 - Elevator: 2025-01-08 Adson Periosteal Elevator Curved Semi-Sharp 17cm
• 00840199507795 - Elevator: 2025-01-08 Woodson Elevator Spatula 26cm 10-1/2" Length