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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 Oviduct Atraumatic Grasper, Standard Length FDA UDI
Model / Reference
SD 16610 FDA UDI
Description
5mm Oviduct Atraumatic Grasper, Standard Length FDA UDI

Identifiers

Catalog Number
SD 16610 FDA UDI
Primary DI / UDI-DI
B382SD166100 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
Not 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

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

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 53abb399-ac42-47b2-9ba3-afe628be61ef 37 fields · synced May 31, 2026