Cryomatic 2.5mm Std Ret Pencil

FDA UDI

Class II (US FDA UDI)

by Keeler Limited

Identity

Trade Name: Cryomatic 2.5mm Std Ret Pencil FDA UDI
Generic Name: Ophthalmic cryosurgical system, electronic FDA UDI
Model / Reference: 2509-P-8000 FDA UDI

Identifiers

Primary DI / UDI-DI: 05055272707640 FDA UDI
FDA Product Code: HRN FDA UDI
GMDN Term: Ophthalmic cryosurgical system, electronic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4170 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic cryosurgical system, electronic

Cryomatic 2.5mm Std Ret Pencil by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic cryosurgical system, electronic.

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2.5mm Extended Retinal Pencil — KEELER LIMITED · Class II
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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 II	Pending data

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Manufacturer

Manufacturer: Keeler Limited

Sources (1)

FDA UDI 21e1ed13-51c6-4c0d-964d-6706e96d855c 32 fields · synced Jun 1, 2026