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Edintrak

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
EDINTRAK FDA UDI
Generic Name
Endoscopic surgical probe FDA UDI
Device Name
Probe FDA UDI
Model / Reference
4034 FDA UDI
Description
Probe FDA UDI

Identifiers

Catalog Number
4034 FDA UDI
Primary DI / UDI-DI
07613327362848 FDA UDI
510(k) Number
K940230 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Endoscopic surgical probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic surgical probe

Edintrak by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic surgical probe.

Cleared under the same submission

K940230 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 55771461-933e-49ca-87af-38d67f75695e 35 fields · synced May 31, 2026