Disposable Backflush instrument, with blunt needle and passive aspiration.(20 ga 1281.AD

GUDID 18717872003600

Disposable Backflush instrument, with blunt needle and passive aspiration.(20 gauge / 0.9 mm)

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

Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula Vitrectomy fluid/gas handling handpiece/cannula
Primary Device ID18717872003600
NIH Device Record Key3f4ca3fb-600b-4c29-b51e-14cefb2145b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Backflush instrument, with blunt needle and passive aspiration.(20 ga
Version Model Number1281.AD
Catalog Number1281.AD
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count5
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
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS108717872003603 [Primary]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]
GS118717872003600 [Unit of Use]

FDA Product Code

HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic
HMXCannula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-22
Device Publish Date2021-02-01

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

08717872008660 - Microforceps: Avci Foreign Body.(17 gauge / 1.5 mm)2021-02-24
08717872008714 - Microforceps: Asymmetrical endgripping.(23 gauge / 0.6 mm)2021-02-24
18717872008735 - Disposable Microforceps: Asymmetrical endgripping.(25 gauge / 0.5 mm)2021-02-24
08717872017709 - Microscissors: Ovali Spatula / Scissors (23 gauge / 0.6 mm)2021-02-24
18717872018567 - Disposable Microscissors: Hooked. (27 gauge / 0.4 mm)2021-02-24
18717872026135 - Backflush Instrument with 23 gauge / 0.6 mm brush needle and active aspiration.2021-02-24
18717872026142 - Backflush Instrument with 20 gauge / 0.9 mm brush needle.2021-02-24
18717872026159 - Backflush Instrument with 20 gauge / 0.9 mm blunt needle.2021-02-24

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.