Cryo Probe: Extended Retinal, 2.5mm 1540.D

GUDID 08717872021416

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ophthalmic cryosurgical system, electronic
Primary Device ID08717872021416
NIH Device Record Keya3c9012a-412f-4ecc-9abd-03c51b73a752
Commercial Distribution Discontinuation2024-05-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCryo Probe: Extended Retinal, 2.5mm
Version Model Number1540.D
Catalog Number1540.D
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872021416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRNUnit, Cryophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-01-23
Device Publish Date2017-07-12

Devices Manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

08717872001401 - Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max.2026-01-23
08717872001425 - Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max.2026-01-23
08717872003085 - Infusion cannula forceps2026-01-23
08717872003115 - Scleral plug forceps2026-01-23
08717872003375 - Charles Flute instrument.2026-01-23
08717872004280 - Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.2026-01-23
08717872008578 - Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.2026-01-23
08717872016771 - Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max2026-01-23

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