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Pomee

FDA UDI

Class I (US FDA UDI)

by Pomee Corporation

Identity

Trade Name
Pomee FDA UDI
Generic Name
Dental wax carver FDA UDI
Device Name
Hollenback Carvers #3 FDA UDI
Model / Reference
703-200 FDA UDI
Description
Hollenback Carvers #3 FDA UDI

Identifiers

Catalog Number
703-200 FDA UDI
Primary DI / UDI-DI
G1577032000 FDA UDI
FDA Product Code
EKG FDA UDI
GMDN Term
Dental wax carver FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental wax carver

Pomee by Pomee Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental wax carver.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pomee Corporation

Sources (1)

  • FDA UDI a3803a21-0f7f-4fe7-bd4a-d1e98cd30653 34 fields · synced May 30, 2026