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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, Push Button FDA UDI
Model / Reference
0703-046-005 FDA UDI
Description
SafeAir Telescopic Smoke Evacuation Pencil, Uncoated, 70mm Blade, Push Button FDA UDI

Identifiers

Catalog Number
0703-046-005 FDA UDI
Primary DI / UDI-DI
07613327466348 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

Yes

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
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 b0e0c666-2e0f-4f7c-ac30-4c998d0fb7eb 36 fields · synced May 29, 2026