Isoglide

Basic Information

• Brand Name: Isoglide
• Primary DI: 00860006638726
• Version / Model: Isoglide 5-pack
• Company Name: Zalinsky Ortho Parts, LLC
• Labeler DUNS: 840462498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: 53be528b-8684-4d4c-ad7d-1d212001405c

Device Description

Orthodontic Eruption Spring- 5 pack (individual parts are not labeled for individual sale)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECO	Spring, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31797	Orthodontic spring	A dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006638726	GS1