2.5mm Mid-Reach Retinal Pencil

FDA UDI

Class II (US FDA UDI)

by Keeler Limited

Identity

Trade Name: 2.5mm Mid-Reach Retinal Pencil FDA UDI
Generic Name: Ophthalmic cryosurgical system, electronic FDA UDI
Model / Reference: 2509-P-8002 FDA UDI

Identifiers

Primary DI / UDI-DI: 05055272707664 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

2.5mm Mid-Reach Retinal Pencil by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic cryosurgical system, electronic.

Cryo Probe: Extended Retinal, 2.5mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
Frigitronics — CooperSurgical, Inc. · Class II
Cryomatic 2.5mm Std Ret Pencil — KEELER LIMITED · Class II
3mm Glaucoma Pencil — KEELER LIMITED · Class II
ADAPTOR FOR F SIZE N2O CYLINDER — KEELER LIMITED · Class II
2.5mm Extended Retinal Pencil — KEELER LIMITED · Class II
ADAPTOR FOR F SIZE CO2 CYLINDER — KEELER LIMITED · Class II
1.5mm Curved Cataract Pencil — KEELER LIMITED · Class II

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

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

Manufacturer

Manufacturer: Keeler Limited

Sources (1)

FDA UDI 13a77c74-7c1b-4c98-8dfe-cf74db8c0448 32 fields · synced Jun 8, 2026