PKIT HANA STERILE AATHA DRAPE 6 KITS /CS

GUDID 00842430116360

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Patient surgical drape, single-use

• Primary Device ID: 00842430116360
• NIH Device Record Key: f7f4fece-ef4c-46bb-b273-b424d8ffd68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKIT HANA STERILE AATHA DRAPE 6 KITS /CS
• Version Model Number: 6855SDKL-6
• Company DUNS: 084527241
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430116339 [Primary]
GS1	00842430116360 [Unit of Use]

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

• 00842430109140 - ADANTE KNEE PROCEDURE KIT, LEFT: 2025-08-05 Contains 6895TKA-L-CS Adante Knee Drape System, Left (case of 5) and 6895-75-5 Adante Knee Protection Kit (case of 5)
• 00842430109157 - ADANTE KNEE PROCEDURE KIT, RIGHT: 2025-08-05 Contains 6895TKA-L-CS Adante Knee Drape System, Right (case of 5) and 6895-75-5 Adante Knee Protection Kit (case of 5)
• 00842430109164 - ADANTE DAA HIP PROCEDURE KIT, LEFT: 2025-08-05 Contains 6895THA-L-CS Adante DAA-THA Drape, Left (case of 5) and 6895-76-5 Adante Hip Protection Kit (case of 5)
• 00842430109171 - ADANTE DAA HIP PROCEDURE KIT, RIGHT: 2025-08-05 Contains 6895THA-R-CS Adante DAA-THA Drape, Right (case of 5) and 6895-76-5 Adante Hip Protection Kit (case of 5)
• 00842430116728 - TRAPEZE ARM ASSEMBLY, PATIENT HELPER: 2025-08-05
• 00842430116261 - KIT, HANA SSXT MAQUET 1140 VERSION: 2025-01-20
• 10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1): 2024-05-20
• 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB: 2024-03-15