Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Peritoneal catheter stylet FDA UDI
Device Name: 25 Inch Shunt Peritoneal Catheter Passer W/ Small Round T-Handle and Female Luer Lock, 2 Piece, Cannula 4.2mm, Probe 3.5mm FDA UDI
Model / Reference: SD48-1716 FDA UDI
Description: 25 Inch Shunt Peritoneal Catheter Passer W/ Small Round T-Handle and Female Luer Lock, 2 Piece, Cannula 4.2mm, Probe 3.5mm FDA UDI

Identifiers

Catalog Number: SD48-1716 FDA UDI
Primary DI / UDI-DI: B382SD4817160 FDA UDI
FDA Product Code: GEN FDA UDI
GMDN Term: Peritoneal catheter stylet FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Peritoneal catheter stylet

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

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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

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Manufacturer

Manufacturer: Surgical Direct, Inc.

Sources (1)

FDA UDI fd115fff-2d9b-4b5b-b699-866106995da2 35 fields · synced May 30, 2026