FDA.reportPublic FDA data

Aveta Opal Disposable Hysteroscope, 4.6mm

Primary DI
00850006759576
Brand
Aveta Opal Disposable Hysteroscope, 4.6mm
Company
MEDITRINA, INC.
Model
220-2002
Catalog number
220-2002
Device description
Aveta Opal Disposable Hysteroscope, 4.6mm for use with Aveta System
Published
2021-06-23
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
00850006759576PackageGS16In Commercial Distribution
00850006759569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006759576008500067595768500067595760850006759576
00850006759569008500067595698500067595690850006759569

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeAn electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). 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
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
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