Isoglide

GUDID 00860006638702

Orthodontic Eruption Spring

Zalinsky Ortho Parts, LLC

Orthodontic spring

• Primary Device ID: 00860006638702
• NIH Device Record Key: e337910e-fc27-4726-aaa1-d5cedaeffb4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isoglide
• Version Model Number: Isoglide 1-pack
• Company DUNS: 840462498
• Company Name: Zalinsky Ortho Parts, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006638702 [Primary]

FDA Product Code

• ECO: Spring, Orthodontic

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: 2021-07-19
• Device Publish Date: 2021-07-11

On-Brand Devices [Isoglide]

• 00860006638702: Orthodontic Eruption Spring
• 00860006638733: Orthodontic Eruption Spring- 10 pack (individual parts are not labeled for individual sale)
• 00860006638726: Orthodontic Eruption Spring- 5 pack (individual parts are not labeled for individual sale)
• 00860006638719: Orthodontic Eruption Spring- 3 pack (individual parts are not labeled for individual sale)