Velpro

GUDID 00190707005122

TEAL VELPRO NECK PAD WITH BLACK CLIP

ORTHO ORGANIZERS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190707005122
• NIH Device Record Key: b047da2d-ba9c-4b92-839b-947e1e859dd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velpro
• Version Model Number: 426-074
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00190707005122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940410

FDA Product Code

• DZB: Headgear, extraoral, orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Velpro]

• 00190707005122: TEAL VELPRO NECK PAD WITH BLACK CLIP
• 00190707005115: BLUE VELPRO NECK PAD WITH BLACK CLIP
• 00190707005108: PINK VELPRO NECK PAD WITH BLACK CLIP
• 00190707005092: PURPLE VELPRO NECK PAD WITH BLACK CLIP
• 00190707005085: BLACK VELPRO NECK PAD WITH BLACK CLIP