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Stryker

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Stryker FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
SafeAir Telescopic Smoke Evacuation Pencil, Uncoated, 70mm Blade, Rocker Switch, Non-Sterile FDA UDI
Model / Reference
0703-047-007 FDA UDI
Description
SafeAir Telescopic Smoke Evacuation Pencil, Uncoated, 70mm Blade, Rocker Switch, Non-Sterile FDA UDI

Identifiers

Catalog Number
0703-047-007 FDA UDI
Primary DI / UDI-DI
07613327465693 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use 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

No

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

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

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 0365681c-af4c-417b-b73a-bd9de345042a 36 fields · synced May 30, 2026