AMO TAC INFUSION SLEEVE OM0527011

GUDID 05050474520509

PARTS LIST, INFUSION SLEEVE ASEMBLY

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitrectomy system handpiece
Primary Device ID05050474520509
NIH Device Record Key4df08633-375f-4f97-81ac-7d2951d3d6a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMO TAC INFUSION SLEEVE
Version Model NumberOM0527011
Catalog NumberOM0527011
Company DUNS103021940
Company NameJOHNSON & JOHNSON SURGICAL VISION, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474520509 [Primary]

FDA Product Code

HKPINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-26
Device Publish Date2016-09-02

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