FDA.reportPublic FDA data

Aveta Disposable Resecting Device 3.9 mm

Primary DI
00850006759194
Brand
Aveta Disposable Resecting Device 3.9 mm
Company
MEDITRINA, INC.
Model
216-041
Catalog number
216-041
Device description
Aveta Disposable Resecting Device 3.9 mm for use with Aveta System
Published
2019-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190372000Aveta SystemMeditrina, Inc.2019-05-16HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006759194PackageGS13In Commercial Distribution
00850006759095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006759194008500067591948500067591940850006759194
00850006759095008500067590958500067590950850006759095

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece, line-poweredA hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080570262
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006759835Aveta Tissue Catch with Tubing205-2052205-20522026-03-20
00850006759842Aveta Tissue Catch with Tubing205-2052205-20522026-03-20
00850006759811Aveta Drape Pump212-081212-0812025-04-11
00850006759033Aveta Roll Stand with Drape Pump212-205212-2052019-11-26
00850006759699Aveta Waste Management Accessory205-2036205-20362024-10-14
00850006759736Aveta Waste Bag with Tissue Catch205-2037205-20372024-10-14
00850006759705Aveta Waste Management Accessory205-2036205-20362024-10-14
10850006759733Aveta Waste Bag with Tissue Catch205-2037205-20372024-10-14
00850006759460Aveta Smol Disposable Resecting Device, 2.9 mm204-239204-2392024-04-26
00850006759484Aveta Smol Disposable Resecting Device, 2.9 mm204-210204-2102024-04-26
00850006759613Aveta Smol Disposable Resecting Device, 2.9 mm216-2008216-20082024-04-26
00850006759477Aveta Smol Disposable Resecting Device, 2.9 mm204-239204-2392024-04-26
00850006759491Aveta Smol Disposable Resecting Device, 2.9 mm204-210204-2102024-04-26
00850006759620Aveta Smol Disposable Resecting Device, 2.9 mm216-2008216-20082024-04-26
00850006759712Aveta Flex+ Disposable Resecting Device, 2.9 mm210-2011210-20112023-12-01
00850006759729Aveta Max+ Disposable Resecting Device, 3.9 mm210-2013210-20132023-12-01
10850006759719Aveta Flex+ Disposable Resecting Device, 2.9 mm210-2011210-20112023-12-01
10850006759726Aveta Max+ Disposable Resecting Device, 3.9 mm210-2013210-20132023-12-01
00850006759163Aveta Tissue Catch205-259205-2592023-08-16
00850006759224Aveta Tissue Catch205-259205-2592023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744080TruClearCovidien LPHIH2017-10-16
10884521744097TruClearCovidien LPHIH2017-10-16
10884521744103TruClearCovidien LPHIH2017-10-16
10884521744110TruClearCovidien LPHIH2017-10-16