Replacement backflush reservoir with active aspiration. 1281.XD

GUDID 18717872004027

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
Primary Device ID18717872004027
NIH Device Record Key30d46d6c-67f2-41f5-b8d2-3f62dd431930
Commercial Distribution StatusIn Commercial Distribution
Brand NameReplacement backflush reservoir with active aspiration.
Version Model Number1281.XD
Catalog Number1281.XD
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
GS108717872004020 [Primary]
GS118717872004027 [Unit of Use]

FDA Product Code

HMXCannula, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

On-Brand Devices [Replacement backflush reservoir with active aspiration.]

187178720040271281.XD
187178720040101281.XD

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