Endotrac

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: ENDOTRAC FDA UDI
Generic Name: Rigid endoscope obturator FDA UDI
Device Name: Gastorcnemius Obturator FDA UDI
Model / Reference: 3031-G FDA UDI
Description: Gastorcnemius Obturator FDA UDI

Identifiers

Catalog Number: 3031-G FDA UDI
Primary DI / UDI-DI: 07613327356519 FDA UDI
510(k) Number: K940230 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Rigid endoscope obturator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope obturator

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

Similar devices

Also classified as Rigid endoscope obturator.

Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
TAUT — TELEFLEX INCORPORATED · Class II
Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
USA Elite — Gyrus Acmi, Inc. · Class II
Trabecular Metal® — Zimmer, Inc. · Class I
SHARK — Richard Wolf GmbH · Class II

Cleared under the same submission

K940230 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI fa0d5c75-5091-4615-a0ff-c6f6650bd550 35 fields · synced Jun 8, 2026