Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Laparoscopic access cannula, reusable FDA UDI
Device Name: 8 1/2" Fischer Tonsil Knife & Dissector, 15mm Curved Blade, Sharp Edge, Flat Tip, Top Edge Serrated, Insulated FDA UDI
Model / Reference: SD903478108 FDA UDI
Description: 8 1/2" Fischer Tonsil Knife & Dissector, 15mm Curved Blade, Sharp Edge, Flat Tip, Top Edge Serrated, Insulated FDA UDI

Identifiers

Catalog Number: SD903478108 FDA UDI
Primary DI / UDI-DI: B382SD9034781080 FDA UDI
FDA Product Code: NBH FDA UDI
GMDN Term: Laparoscopic access cannula, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Laparoscopic access cannula, reusable

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

Similar devices

Also classified as Laparoscopic access cannula, reusable.

Single-Site — Intuitive Surgical, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
ELMED — ELMED INCORPORATED · Class II
Gimmi — Gimmi GmbH · Class II
BLUEENDO — TROKAMED GmbH · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
AESCULAP — AESCULAP, INC. · Class II
Gimmi — Gimmi GmbH · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Surgical Direct, Inc.

Sources (1)

FDA UDI af13ca0a-466c-45dd-9404-984d91bb6de5 35 fields · synced Jun 8, 2026