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Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name
MR PHACO FDA UDI
Generic Name
Ophthalmic suture/needle passer FDA UDI
Device Name
Castroviejo Needle Holder Standard Curved 11mm Smooth Jaws, With Lock, Flat Serrated Handle, 140mm Overall Length, Titanium FDA UDI
Model / Reference
PH3121T FDA UDI
Description
Castroviejo Needle Holder Standard Curved 11mm Smooth Jaws, With Lock, Flat Serrated Handle, 140mm Overall Length, Titanium FDA UDI

Identifiers

Primary DI / UDI-DI
G412PH3121T0 FDA UDI
FDA Product Code
HNM FDA UDI
GMDN Term
Ophthalmic suture/needle passer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic suture/needle passer

Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic suture/needle passer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crestpoint Management Ltd.

Sources (1)

  • FDA UDI 6721c6a0-ffb8-4054-ab0d-4b89008e4b48 33 fields · synced May 30, 2026