← Back to catalogue

HME 10 Basic

FDA UDI

Class I (US FDA UDI)

by Pharma Systems Ps AB

Identity

Trade Name
HME 10 Basic FDA UDI
Generic Name
Electrocautery system generator, line-powered FDA UDI
Device Name
HME FDA UDI
Model / Reference
6060 FDA UDI
Description
HME FDA UDI

Identifiers

Catalog Number
6060 FDA UDI
Primary DI / UDI-DI
30734000671342 FDA UDI
FDA Product Code
BYD FDA UDI
GMDN Term
Electrocautery system generator, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5375 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 7.3 Centimeter FDA UDI

Category: Electrocautery system generator, line-powered

HME 10 Basic by Pharma Systems Ps AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocautery system generator, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pharma Systems Ps AB

Sources (1)

  • FDA UDI e242dbc7-6456-4056-9c37-028df23bbfb3 36 fields · synced May 30, 2026