TLC Cradle Boot 1917

GUDID 00842430111778

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Heel protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector Foot friction/impact protector

• Primary Device ID: 00842430111778
• NIH Device Record Key: 2062f482-503f-4dd2-8d13-8759f65f7b3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLC Cradle Boot
• Version Model Number: 1917
• Catalog Number: 1917
• 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: false
• 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: false
• 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
• 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	00842430111778 [Primary]

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

• 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
• 00842430103414 - UPPER ARM SUPPORT & PAD, REFURBISHED: 2023-09-27