Castroviejo Needle Holder (curved) (non glare)

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Castroviejo Needle Holder (curved) (non glare) FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser. FDA UDI
Model / Reference: 25-014 FDA UDI
Description: The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660003419 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Suturing needle holder, reusable 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 5.5 Inch FDA UDI
Length — 14 Centimeter FDA UDI

Category: Suturing needle holder, reusable

Castroviejo Needle Holder (curved) (non glare) by Oculo-Plastik 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: Oculo-Plastik Inc

Sources (1)

FDA UDI a1c59a56-f5ad-45e2-b7c1-32a0c32144d6 35 fields · synced May 30, 2026