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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Suction system catheter, general-purpose FDA UDI
Device Name
2mm 20cm Kleinsasser Style Suction Cannula, Matte Finish, Reinforced Shaft, Tapered to 1mm With Closed Tip, 2 Lateral Opening, Angled Down Handle With Finger Control Cushion and Barb Hose Fitting FDA UDI
Model / Reference
SD67-8692-01 FDA UDI
Description
2mm 20cm Kleinsasser Style Suction Cannula, Matte Finish, Reinforced Shaft, Tapered to 1mm With Closed Tip, 2 Lateral Opening, Angled Down Handle With Finger Control Cushion and Barb Hose Fitting FDA UDI

Identifiers

Catalog Number
SD67-8692-01 FDA UDI
Primary DI / UDI-DI
B382SD678692010 FDA UDI
FDA Product Code
KCB FDA UDI
GMDN Term
Suction system catheter, general-purpose FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

Yes

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: Suction system catheter, general-purpose

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

Similar devices

Also classified as Suction system catheter, general-purpose.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3b8da6a7-d701-4c1a-9d9c-e840a01ac4dd 35 fields · synced May 30, 2026