Disposable reversed Sinskey hook with irrigation 50.2210

GUDID 18717872018420

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

Donor cornea delivery set
Primary Device ID18717872018420
NIH Device Record Keyb9fa59de-5f56-4111-bfdb-696d1041c41f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable reversed Sinskey hook with irrigation
Version Model Number50.2210
Catalog Number50.2210
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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
GS108717872018423 [Primary]
GS118717872018420 [Unit of Use]

FDA Product Code

HNDSpatula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

On-Brand Devices [Disposable reversed Sinskey hook with irrigation]

1871787201842050.2210
1871787201919950.2210

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.