CoreTech

Basic Information

• Brand Name: CoreTech
• Primary DI: 00810113573229
• Version / Model: SUP3035BLKXL
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-11
• Public Version: 1
• Public Version Date: 2024-01-19
• Public Version Status: New
• Public Device Record Key: f892300d-08ef-447c-b972-2b55a69cc74c

Device Description

SAFS (Shorts Against FAI Syndrome) XL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45606	Compression/pressure shirt/pants	A garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810113573226	GS1	Case	28	In Commercial Distribution
Primary	00810113573229	GS1