096658

GUDID 02858028005198

ACQUIRE MED

Urogenital surgical laser system beam guide, single-use
Primary Device ID02858028005198
NIH Device Record Key42743362-32f4-4314-aa5e-33dbbca0abf1
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberQ-365-KTP
Catalog Number096658
Company DUNS061766352
Company NameACQUIRE MED
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 Datetrue
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
GS100858028005190 [Primary]
GS101858028005199 [Package]
Contains: 00858028005190
Package: [5 Units]
In Commercial Distribution
GS102858028005198 [Package]
Contains: 01858028005199
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

Devices Manufactured by ACQUIRE MED

02816901023448 - Acquire Med2023-06-05
02816901022984 - Acquire Med2021-06-22
02816901022816 - LEONI™2021-06-09
02816901022823 - Acquire Med2021-06-09
01816901022831 - Acquire Med2021-06-09
02816901022847 - Acquire Med2021-06-09
01816901022855 - Acquire Med2021-06-09
01858028005083 - NA2018-11-15

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