MR Phaco PH2215

by Crestpoint Management Ltd.

MR Phaco PH2215 is a Class I device made by Crestpoint Management Ltd., listed in FDA GUDID since 27 May 2025 (UDI-DI G412PH22150), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberG412PH22150 UDI-DI	Date27 May 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: MR Phaco
Generic name: Ophthalmic surgical device handling forceps, reusable
Model / reference: PH2215

Primary DI / UDI-DI: G412PH22150
FDA product code: HNR
GMDN term: Ophthalmic surgical device handling forceps, reusable

Device class: Class I
Regulation number: 886.4350
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Ophthalmic surgical device handling forceps, reusable.

Other devices from Crestpoint Management Ltd.

MR Phaco PH2400

Class I
MR Phaco PH1793RT

Class I
MR Phaco CA469

Class I
MR Phaco PH1900T

Class I

See all devices from Crestpoint Management Ltd. →

Properties

Sterilise before use
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (11, all answered No)