Tilting Arm Black Belt Retractor Starter Set 7319-98A

GUDID 00840199501717

Tilting Arm Black Belt Retractor Starter Set Consisting of the Following: 1x 7320-22A - Tilting Arm Retractor frame Right, 1x 7320-30A - Tilting Arm Retractor frame Offset, 2x 7320-40 - Blade Inserting Angled Clamp, 2x 7322-34 - Pronged Blade 34 mm, 2x 7322-40 - Pronged Blade 40 mm, 2x 7322-45 - Pronged Blade 45 mm, 2x 7322-50 - Pronged Blade 50 mm, 2x 7322-55 - Pronged Blade 55 mm, 2x 7322-60 - Pronged Blade 60 mm, 2x 7324-34 - Blunt Blade 34 mm, 2x 7324-40 - Blunt Blade 40 mm, 2x 7324-45 - Blunt Blade 45 mm, 2x 7324-50 - Blunt Blade 50 mm, 2x 7324-55 - Blunt Blade 55 mm, 2x 7324-60 - Blunt Blade 60 mm, 1x 7319-90 - Sterilizing Instrument Case, 1.5 x 11 x 13"

KOROS U.S.A., INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00840199501717
• NIH Device Record Key: d36ee32e-bbe4-42f9-9349-e64cc65676e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tilting Arm Black Belt Retractor Starter Set
• Version Model Number: 7319-98A
• Catalog Number: 7319-98A
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199501717 [Direct Marking]
GS1	10840199501714 [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

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

[00840199501717]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-06
• Device Publish Date: 2021-06-28

On-Brand Devices [Tilting Arm Black Belt Retractor Starter Set]

• 00840199501731: Tilting Arm Clearview Black Belt Retractor Starter Set Consisting of the Following: Stainless St
• 00840199501717: Tilting Arm Black Belt Retractor Starter Set Consisting of the Following: 1x 7320-22A - Tilting