Mr Phaco

FDA UDI

Class I (US FDA UDI)

by Crestpoint Management Ltd.

Identity

Trade Name: MR PHACO FDA UDI
Generic Name: Orbital depressor, reusable FDA UDI
Device Name: Schocket Scleral Depressor DBL-Ended T-Shaped Hammer Head tip, / Half Ball-Shaped tip, Both Sides are Slightly Angled 16mm from bend to tip, Comes with Pocket clip, Flat Handle, 137mm Overall Length, Stainless Steel FDA UDI
Model / Reference: DP2060 FDA UDI
Description: Schocket Scleral Depressor DBL-Ended T-Shaped Hammer Head tip, / Half Ball-Shaped tip, Both Sides are Slightly Angled 16mm from bend to tip, Comes with Pocket clip, Flat Handle, 137mm Overall Length, Stainless Steel FDA UDI

Identifiers

Primary DI / UDI-DI: G412DP20600 FDA UDI
FDA Product Code: HNX FDA UDI
GMDN Term: Orbital depressor, reusable 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orbital depressor, reusable

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

Similar devices

Also classified as Orbital depressor, reusable.

Ambler Surgical — Ambler Surgical, LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
Schepens Scleral Depressor — SONTEC INSTRUMENTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Crestpoint Management Ltd.

Sources (1)

FDA UDI 20d52a4c-c997-484a-9065-381b781c2337 33 fields · synced Jun 8, 2026