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Frigitronics

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Frigitronics FDA UDI
Generic Name
Ophthalmic cryosurgical system applicator, retinal FDA UDI
Device Name
2.08mm Pediatric Retinal Curved Probe. Tip: 1.0mm length x 2.08mm diameter. Shaft: 27mm length x 2.84mmmm diameter FDA UDI
Model / Reference
121 FDA UDI
Description
2.08mm Pediatric Retinal Curved Probe. Tip: 1.0mm length x 2.08mm diameter. Shaft: 27mm length x 2.84mmmm diameter FDA UDI

Identifiers

Primary DI / UDI-DI
00888937004335 FDA UDI
FDA Product Code
HQA FDA UDI
GMDN Term
Ophthalmic cryosurgical system applicator, retinal 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic cryosurgical system applicator, retinal

Frigitronics by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic cryosurgical system applicator, retinal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI fffc2bd6-b749-463c-a010-82fb1d880562 33 fields · synced Jun 9, 2026