Black Belt Micro Discectomy Attachment Set 7321-00M

GUDID 00840199502424

Black Belt Micro Discectomy Attachment Set Consisting of the following: 1x7321-10M BB Cervical Retractor Titanium Micro Discectomy Adaptor 1x7321-20M BB Cervical Retractor Spike Blade 70mm Titanium 1x7321-30M BB Cervical Retractor T-Shape Blade 70mm Titanium 1x7321-40M Black Belt Inner Spine Ligament Blade 70mm Titanium 1x7322-85M Black Belt Pronged Ti Blade 22x85mm

KOROS U.S.A., INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable

• Primary Device ID: 00840199502424
• NIH Device Record Key: 27022572-998d-4d6f-ae67-3722cf9618c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Belt Micro Discectomy Attachment Set
• Version Model Number: 7321-00M
• Catalog Number: 7321-00M
• 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
• 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
• 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	00840199502424 [Direct Marking]
GS1	10840199502421 [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

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

[00840199502424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

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

• 00840199514434 - Black Belt Retractor Container Tray: 2024-04-11 Black Belt Retractor Container Tray with Lid 21.25" x 10" x 2.75"
• 00840199523405 - Dissector: 2024-02-14 Spinal Adjustable Length Penfield Dissector 5mm, 26-42cm Length
• 00840199533305 - Dissector: 2024-02-14 Rhoton Type Dissector No. 1
• 00840199533312 - Dissector: 2024-02-14 Rhoton Type Dissector No. 2
• 00840199533329 - Dissector: 2024-02-14 Rhoton Type Dissector No. 3
• 00840199533350 - Dissector: 2024-02-14 Rhoton Type Spatula Dissector No. 6
• 00840199533367 - Dissector: 2024-02-14 Rhoton Type Spatula Dissector No. 7
• 00840199533374 - Dissector: 2024-02-14 Rhoton Type Spatula Dissector No. 8