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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
Uterine manipulator, reusable FDA UDI
Device Name
Cohen Cannula with Two Adaptors, Large and Small FDA UDI
Model / Reference
SD92350910 FDA UDI
Description
Cohen Cannula with Two Adaptors, Large and Small FDA UDI

Identifiers

Catalog Number
SD92350910 FDA UDI
Primary DI / UDI-DI
B382SD923509100 FDA UDI
510(k) Number
K974382 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Uterine manipulator, reusable 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

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: Uterine manipulator, reusable

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

Similar devices

Also classified as Uterine manipulator, reusable.

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 bb002964-7d75-4d01-9e69-3ce42c533c2e 36 fields · synced Jun 1, 2026