INSOLE XPE FRDM SIZE 8 M 14

Basic Information

• Brand Name: INSOLE XPE FRDM SIZE 8 M 14
• Primary DI: 00733657223675
• Version / Model: 6838
• Catalog Number: 2970008040
• Company Name: ALIMED, INC.
• Labeler DUNS: 056007248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 8c8718a5-518e-435d-bfdf-263f975e710e

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: Yes
• 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: Yes
• 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
KYS	INSOLES, MEDICAL	General Hospital	880.6280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41575	Orthotic insole, prefabricated, non-antimicrobial	A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733657223675	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]