Precision Bipolar

GUDID 10803622132459

LIVANOVA USA, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID10803622132459
NIH Device Record Keya42eb4c8-5c4f-4124-9de1-9dda66ae372b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Bipolar
Version Model NumberPBD02
Company DUNS080914995
Company NameLIVANOVA USA, INC.
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 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
GS100803622132452 [Primary]
GS110803622132459 [Package]
Contains: 00803622132452
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-06-15

Devices Manufactured by LIVANOVA USA, INC.

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00803622156533 - Perfusion Pack2024-04-23
00803622156540 - Perfusion Pack2024-04-23
10803622156554 - Perfusion Pack2024-04-23
10803622156561 - Perfusion Pack2024-04-23
10803622156592 - Cardioplegia Pack2024-04-23

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