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Elements by Hedy Barrier Envelopes

FDA UDI

Class II (US FDA UDI)

by AMD Medicom Inc

Identity

Trade Name
Elements by Hedy Barrier Envelopes FDA UDI
Generic Name
Digital imaging cassette/storage phosphor screen, dental FDA UDI
Device Name
Dental Barrier Sleeves for Phosphor Storage Plates, Size Large FDA UDI
Model / Reference
HE-BEHO2 FDA UDI
Description
Dental Barrier Sleeves for Phosphor Storage Plates, Size Large FDA UDI

Identifiers

Catalog Number
HE-BEHO2 FDA UDI
Primary DI / UDI-DI
D903HEBEHO2 FDA UDI
FDA Product Code
PEM FDA UDI
GMDN Term
Digital imaging cassette/storage phosphor screen, dental FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Digital imaging cassette/storage phosphor screen, dental

Elements by Hedy Barrier Envelopes by AMD Medicom Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digital imaging cassette/storage phosphor screen, dental.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMD Medicom Inc

Sources (1)

  • FDA UDI 9161aef4-e821-451b-ab33-41d2dadfa8af 34 fields · synced May 31, 2026