← Back to catalogue

Surgical Direct

FDA UDI

Class II (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
9 3/4" Hardy Bayonet Bipolar Forceps, Silver Straight Needle Tips, Insulated FDA UDI
Model / Reference
SD03098-11001-1 FDA UDI
Description
9 3/4" Hardy Bayonet Bipolar Forceps, Silver Straight Needle Tips, Insulated FDA UDI

Identifiers

Catalog Number
SD03098-11001-1 FDA UDI
Primary DI / UDI-DI
B382SD030981100110 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.

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
Surgical Direct, Inc.

Sources (1)

  • FDA UDI b73545e6-5f13-4cee-86dc-ee1fa77c96b8 35 fields · synced May 30, 2026