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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
Surgical fluid/smoke waste management system FDA UDI
Device Name
PENCIL, CAUTERY, PTFE, SMOKE EVAC,ROCKER FDA UDI
Model / Reference
ERKSMOKE3002P FDA UDI
Description
PENCIL, CAUTERY, PTFE, SMOKE EVAC,ROCKER FDA UDI

Identifiers

Catalog Number
ERKSMOKE3002P FDA UDI
Primary DI / UDI-DI
10193489181708 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Surgical fluid/smoke waste management system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

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: Surgical fluid/smoke waste management system

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical fluid/smoke waste management system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 97c4e889-1c1f-4b1d-8b7a-f2f83f692637 36 fields · synced May 30, 2026