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Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name
MICROTEK FDA UDI
Generic Name
Surgical fluid/smoke waste management system suction unit FDA UDI
Device Name
Switch remote Versavac 2, 1-CASE FDA UDI
Model / Reference
1 FDA UDI
Description
Switch remote Versavac 2, 1-CASE FDA UDI

Identifiers

Primary DI / UDI-DI
50748426098717 FDA UDI
510(k) Number
K001082 FDA UDI
FDA Product Code
FYD FDA UDI
GMDN Term
Surgical fluid/smoke waste management system suction unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical fluid/smoke waste management system suction unit

Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical fluid/smoke waste management system suction unit.

Cleared under the same submission

K001082 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microtek Medical LLC

Sources (1)

  • FDA UDI b6647a31-7cbd-483c-be7b-9827908ab872 36 fields · synced Jun 8, 2026