PKIT, INDIV W/SHEARGARD, SST-3000 (1) 5819

GUDID 10842430111539

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set

• Primary Device ID: 10842430111539
• NIH Device Record Key: 3abc53c8-5a13-4692-aa91-e0ad02afb525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKIT, INDIV W/SHEARGARD, SST-3000 (1)
• Version Model Number: 5819-1
• Catalog Number: 5819
• Company DUNS: 084527241
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Device Count: 1
• 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: true
• Expiration Date: false
• 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: 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	00842430111532 [Primary]
GS1	10842430111539 [Package]; Contains: 00842430111532; Package: multi-pack [6 Units]; In Commercial Distribution

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-20
• Device Publish Date: 2022-01-05

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

• 10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1): 2024-05-20
• 10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1): 2024-05-20
• 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB: 2024-03-15
• 00842430113727 - FOOT SUPPORT ASSEMBLY: 2024-03-14
• 00842430101212 - Pad Set For GST Tempur-Pedic, 76MM: 2023-09-27
• 00842430101311 - SPAR,LEG,RIGHT RADIOLUCENT,REFURBISHED: 2023-09-27
• 00842430101328 - SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHED: 2023-09-27
• 00842430101335 - SPAR ASSEMBLY, RIGHT, REFURBISHED: 2023-09-27
• 00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED: 2023-09-27