Aveta Max Disposable Resecting Device, 3.9 mm 210-084

GUDID 00850006759354

Aveta Max Disposable Resecting Device, 3.9 mm, for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered
Primary Device ID00850006759354
NIH Device Record Key2d79de36-55e6-42f7-808f-a621264ba1a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAveta Max Disposable Resecting Device, 3.9 mm
Version Model Number210-084
Catalog Number210-084
Company DUNS080570262
Company NameMEDITRINA, 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
GS100850006759323 [Primary]
GS100850006759354 [Package]
Contains: 00850006759323
Package: shelf carton [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIGInsufflator, Hysteroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

Devices Manufactured by MEDITRINA, INC.

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00850006759576 - Aveta Opal Disposable Hysteroscope, 4.6mm 2021-07-01 Aveta Opal Disposable Hysteroscope, 4.6mm for use with Aveta System
00850006759583 - Aveta Opal Reusable Cable2021-07-01 Aveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta System
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