Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Vascular graft tunneller FDA UDI
Device Name: Stylet And Handle for Tunneler Stainless Steel, 25cm, Slight Curved FDA UDI
Model / Reference: SD49229-SC25H FDA UDI
Description: Stylet And Handle for Tunneler Stainless Steel, 25cm, Slight Curved FDA UDI

Identifiers

Catalog Number: SD49229-SC25H FDA UDI
Primary DI / UDI-DI: B382SD49229SC25H0 FDA UDI
FDA Product Code: GEN FDA UDI
GMDN Term: Vascular graft tunneller 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: Vascular graft tunneller

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

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SURGIPROS — SURGIPROS LLC · Class I
Tunneler, Bullet, Spare-part entspricht 03-5360.KA — Geister Medizin Technik GmbH · Class I
Screw Olive Tip Ø 6.0 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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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 e8a354a7-3358-4e0b-9121-b7f5c590e27f 35 fields · synced Jun 8, 2026