Apollo System

GUDID 00814548016375

Apollo Pump Canister Kit

PENUMBRA, INC.

Surgical irrigation/aspiration system Surgical irrigation/aspiration system
Primary Device ID00814548016375
NIH Device Record Key352c174c-ddbc-4d27-94e8-262f32a3744d
Commercial Distribution StatusIn Commercial Distribution
Brand NameApollo System
Version Model NumberAPCAN1-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548016375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-03

On-Brand Devices [Apollo System]

00814548017563Apollo Pump, 110V
00814548016474Apollo IV Pole
00814548016382Apollo Generator
00814548016375Apollo Pump Canister Kit
00814548016368Apollo Irrigation Tubing
00814548016351Apollo Wand, Short
00814548016344Apollo Wand, Long
00814548013619Apollo Pump Canister Kit
00814548013602Apollo Irrigation Tubing
00814548013596Apollo Wand, Short
00814548013589Apollo Wand, Long
00814548012728Apollo IV Pole
00814548012711Apollo Pump
00814548012704Apollo Generator

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