Restcloud

Basic Information

• Brand Name: Restcloud
• Primary DI: 06975837120013
• Version / Model: B07QSFJ8S2
• Company Name: Chengdu Si Hai Mu Ze Technology Co.,Ltd.
• Labeler DUNS: 550747578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: f55b9f1e-841e-4bca-a462-462a76cfcfb5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQK	Orthosis, Cervical	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61203	Wearable cervical spine traction device	An externally-worn orthopaedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders (e.g., discogenic, occupational, sports, whiplash). It may include moulded components that fit superiorly under the chin and base of the skull, and inferiorly over the base of the neck and collar bone, with rods holding the components apart that can be adjusted to apply traction forces by separation. It is intended for use in the home or a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975837120013	GS1