Aveta Disposable Resecting Device 2.9 mm 204-167

GUDID 00850006759187

Aveta Disposable Resecting Device 2.9 mm for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system handpiece, line-powered
Primary Device ID00850006759187
NIH Device Record Key0ad055ec-7dd2-4aad-9d43-aefea00b6882
Commercial Distribution StatusIn Commercial Distribution
Brand NameAveta Disposable Resecting Device 2.9 mm
Version Model Number204-167
Catalog Number204-167
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
GS100850006759088 [Primary]
GS100850006759187 [Package]
Contains: 00850006759088
Package: 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 Date2019-12-06
Device Publish Date2019-11-28

Devices Manufactured by MEDITRINA, INC.

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00850006759675 - Aveta Auto 5 Fr Disposable Resecting Device2022-08-26 Aveta Auto 5 Fr Disposable Resecting Device for use with Aveta System
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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
00850006759552 - Aveta Auto Disposable Resecting Device2021-02-19 Aveta Auto Disposable Resecting Device for use with Aveta System

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