Needle Holder - T/C

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Needle Holder - T/C FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Needle holder is a surgical instrument, similar to a hemostat, used to hold a suturing needle for closing wounds during suturing and surgical procedures. These Needle holders have tungsten carbide tips which give better grip and wear out slower than stainless steel. FDA UDI
Model / Reference: Needle Holder - T/C FDA UDI
Description: Needle holder is a surgical instrument, similar to a hemostat, used to hold a suturing needle for closing wounds during suturing and surgical procedures. These Needle holders have tungsten carbide tips which give better grip and wear out slower than stainless steel. FDA UDI

Identifiers

Catalog Number: Needle Holder - T/C FDA UDI
Primary DI / UDI-DI: 00083208190216 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

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

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, reusable

Needle Holder - T/C by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Suturing needle holder, reusable.

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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: Suncoast Dental, Inc.

Sources (1)

FDA UDI bdfbceb6-367b-4998-925c-aac3b28af596 35 fields · synced May 30, 2026