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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
Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Spoon Curette, 3mm Diameter of Element, 30° Angle FDA UDI
Model / Reference
SD18359 FDA UDI
Description
Spoon Curette, 3mm Diameter of Element, 30° Angle FDA UDI

Identifiers

Catalog Number
SD18359 FDA UDI
Primary DI / UDI-DI
B382SD183590 FDA UDI
FDA Product Code
NBH FDA UDI
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Dimensions & Sizes

Size
Angle — 30 degree FDA UDI
Outer Diameter — 3 Millimeter FDA UDI

Category: Laparoscopic surgical procedure kit, non-medicated, 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 surgical procedure kit, non-medicated, reusable.

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 3989f432-87fd-4bdc-81c8-d6ff39b3abb1 36 fields · synced Jun 1, 2026