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Pomee

FDA UDI

Class I (US FDA UDI)

by Pomee Corporation

Identity

Trade Name
Pomee FDA UDI
Generic Name
Manual dental scaler, reusable FDA UDI
Device Name
TOWNER SCALER #15/30 FDA UDI
Model / Reference
711-708 FDA UDI
Description
TOWNER SCALER #15/30 FDA UDI

Identifiers

Catalog Number
711-708 FDA UDI
Primary DI / UDI-DI
G1577117080 FDA UDI
FDA Product Code
EMS FDA UDI
GMDN Term
Manual dental scaler, reusable 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: Manual dental scaler, reusable

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

Similar devices

Also classified as Manual dental scaler, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pomee Corporation

Sources (1)

  • FDA UDI aecb7b42-ac58-412b-85a4-5d3e031c01f4 34 fields · synced Jun 1, 2026