← Back to catalogue

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
CUSTOM TUBING 1/CS STERILE, 1-CASE FDA UDI
Model / Reference
1 FDA UDI
Description
CUSTOM TUBING 1/CS STERILE, 1-CASE FDA UDI

Identifiers

Primary DI / UDI-DI
50748426090469 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide 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

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

Manufacturer

Manufacturer
Microtek Medical LLC

Sources (1)

  • FDA UDI 1a29f926-3de2-4890-965a-2c9de0ef03d7 36 fields · synced Jun 8, 2026