Mastel Precision Surgical Instruments, Inc.

FDA UDI

Class I (US FDA UDI)

by Mastel Surgical Inc.

Identity

Trade Name: Mastel Precision Surgical Instruments, Inc. FDA UDI
Generic Name: Ophthalmic knife, reusable FDA UDI
Device Name: PHD II Ahmed Super Pentiahm, Corneal View, GL FDA UDI
Model / Reference: 11.316.2011 FDA UDI
Description: PHD II Ahmed Super Pentiahm, Corneal View, GL FDA UDI

Identifiers

Catalog Number: 11.316.2011 FDA UDI
Primary DI / UDI-DI: 00642356110134 FDA UDI
FDA Product Code: HNN FDA UDI
GMDN Term: Ophthalmic knife, 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic knife, reusable

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

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Also classified as Ophthalmic knife, reusable.

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Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Walcott Rx Products — Walcott Rx Product Inc · 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

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Manufacturer

Manufacturer: Mastel Surgical Inc.

Sources (1)

FDA UDI a24fdbf3-de0a-4d47-a0b5-02f37366e08e 35 fields · synced Jun 6, 2026