Aveta Reusable Resecting Handset 211-001

GUDID 00850006759040

Aveta Reusable Resecting Handset

MEDITRINA, INC.

Tissue morcellation system control unit
Primary Device ID00850006759040
NIH Device Record Key7438c52a-e0c6-43c9-a99d-07503321636c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAveta Reusable Resecting Handset
Version Model Number211-001
Catalog Number211-001
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100850006759040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850006759040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-04
Device Publish Date2019-11-26

Devices Manufactured by MEDITRINA, INC.

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10850006759726 - Aveta Max+ Disposable Resecting Device, 3.9 mm2023-12-11 Aveta Max+ Disposable Resecting Device, 3.9 mm, for use with Aveta System
00850006759224 - Aveta Tissue Catch2023-08-24 Aveta Tissue Catch, for use with Aveta System
00850006759675 - Aveta Auto 5 Fr Disposable Resecting Device2022-08-26 Aveta Auto 5 Fr Disposable Resecting Device for use with Aveta System
00850006759606 - Aveta Wave+ Disposable Resecting Device, 3.9 mm2021-08-09 Aveta Wave+ Disposable Resecting Device, 3.9 mm, for use with Aveta System
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
00850006759552 - Aveta Auto Disposable Resecting Device2021-02-19 Aveta Auto Disposable Resecting Device for use with Aveta System

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