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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
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Device Name
5mm 32cm Monopolar RF Electrodes, Spatula Tip, for Disposable Handles FDA UDI
Model / Reference
SD77932-441 FDA UDI
Description
5mm 32cm Monopolar RF Electrodes, Spatula Tip, for Disposable Handles FDA UDI

Identifiers

Catalog Number
SD77932-441 FDA UDI
Primary DI / UDI-DI
B382SD779324410 FDA UDI
510(k) Number
K974382 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

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: Flexible endoscopic tissue manipulation forceps, single-use

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

Similar devices

Also classified as Flexible endoscopic tissue manipulation forceps, single-use.

Cleared under the same submission

K974382 also covers:

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 2d98c0a8-4d04-4b3e-99f8-7f7dca345ee6 36 fields · synced May 30, 2026