CVAC Aspiration System

GUDID 20860005357707

Calyxo, Inc.

Intracorporeal lithotripsy suction system
Primary Device ID20860005357707
NIH Device Record Key0528a3ea-1216-46f4-822f-9384e0cf2801
Commercial Distribution StatusIn Commercial Distribution
Brand NameCVAC Aspiration System
Version Model NumberCVAC70
Company DUNS080269404
Company NameCalyxo, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter
Catheter Working Length70 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005357703 [Primary]
GS110860005357700 [Package]
Contains: 00860005357703
Package: [5 Units]
In Commercial Distribution
GS120860005357707 [Package]
Contains: 00860005357703
Package: [2 Units]
In Commercial Distribution
GS130860005357704 [Package]
Contains: 00860005357703
Package: [3 Units]
In Commercial Distribution
GS140860005357701 [Package]
Contains: 00860005357703
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEDEndoscopic Access Overtube, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-09
Device Publish Date2020-12-01

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