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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
10 3/4" Malis Bayonet Bipolar Forceps with Irrigation, Gold Straight .5mm Tips, Insulated FDA UDI
Model / Reference
SD22108-31005-3 FDA UDI
Description
10 3/4" Malis Bayonet Bipolar Forceps with Irrigation, Gold Straight .5mm Tips, Insulated FDA UDI

Identifiers

Catalog Number
SD22108-31005-3 FDA UDI
Primary DI / UDI-DI
B382SD221083100530 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

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI 6ab65b30-d465-4d5b-bf56-a9e27f368443 35 fields · synced May 30, 2026