Glidewell (UDI 70-1204-GLG0002)
Manufactured by Prismatik Dentalcraft, Inc
Device Regulatory Overview
The Glidewell (Model/Catalog Number: 70-1204-GLG0002) is a medical device manufactured by Prismatik Dentalcraft, Inc. This product is indexed under FDA Product Code / Category Classification QDO within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for...
Technical Specifications
- Model Number
- 70-1204-GLG0002
- Product Code / EMDN
- QDO
- Device Name
- Glidewell Nitrile Powder Free Examination Glove - Small
- Database Sync Date
- 2026-08-09 09:14:59
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Glidewell?
The registered manufacturer of record for Glidewell is Prismatik Dentalcraft, Inc.
What is the Primary UDI-DI identifier for Glidewell?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 70-1204-GLG0002.
What classification code is assigned to this device?
This device is registered under product classification code QDO.
Similar Classification Devices (QDO)
Other Devices by Prismatik Dentalcraft, Inc
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