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Pomee

FDA UDI

Class I (US FDA UDI)

by Pomee Corporation

Identity

Trade Name
Pomee FDA UDI
Generic Name
General-purpose surgical spatula FDA UDI
Device Name
Plaster Spatulas #11R 3 1/2" Flexible Blade FDA UDI
Model / Reference
707-871 FDA UDI
Description
Plaster Spatulas #11R 3 1/2" Flexible Blade FDA UDI

Identifiers

Catalog Number
707-871 FDA UDI
Primary DI / UDI-DI
G1577078710 FDA UDI
FDA Product Code
HND FDA UDI
GMDN Term
General-purpose surgical spatula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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: General-purpose surgical spatula

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

Similar devices

Also classified as General-purpose surgical spatula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pomee Corporation

Sources (1)

  • FDA UDI 70e3dcd4-bccc-459c-9589-98622a27545c 34 fields · synced May 31, 2026