Aveta Smol Disposable Resecting Device, 2.9 mm 216-2008

GUDID 00850006759620

Aveta Wave+ Disposable Resecting Tip, 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

Primary Device ID	00850006759620
NIH Device Record Key	dc8ea5b8-1fab-43c4-9256-05fb547c79de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aveta Smol Disposable Resecting Device, 2.9 mm
Version Model Number	216-2008
Catalog Number	216-2008
Company DUNS	080570262
Company Name	MEDITRINA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006759613 [Primary]
GS1	00850006759620 [Package] Contains: 00850006759613 Package: Shelf carton [3 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190372

FDA Product Code

HIG	Insufflator, Hysteroscopic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

On-Brand Devices [Aveta Smol Disposable Resecting Device, 2.9 mm]

00850006759620	Aveta Wave+ Disposable Resecting Tip, 3.9 mm, for use with Aveta System
00850006759491	Aveta Flex Disposable Resecting Tip, 2.9 mm, for use with Aveta System
00850006759477	Aveta Smol Disposable Resecting Tip, 2.9 mm, for use with Aveta System