Identity
- Trade Name
- Health-Tec/DHP PSP Barrier Envelopes FDA UDI
- Generic Name
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
- Device Name
- Health-Tec/DHP PSP Barrier Envelopes w/Inserts Size 2 200/box FDA UDI
- Model / Reference
- 930-10006 FDA UDI
- Description
- Health-Tec/DHP PSP Barrier Envelopes w/Inserts Size 2 200/box FDA UDI
Identifiers
- Catalog Number
- 930-10006 FDA UDI
- Primary DI / UDI-DI
- D773930100061 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- GMDN Term
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.1905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Digital imaging cassette/storage phosphor screen, dental
Health-Tec/DHP PSP Barrier Envelopes by Dental Health Products Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digital imaging cassette/storage phosphor screen, dental.
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- Phosphor Storage Plate — Air Techniques, Inc. · Class I
- Visionary by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Visionary by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Phosphor Storage Plate — Air Techniques, Inc. · Class I
- Unipack — Unipack Medical Corporation · Class I
- Visionary by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Health Products Inc
Sources (1)
- FDA UDI e0e86af4-913f-4e88-8174-0ac986338d17 34 fields · synced May 30, 2026