FDA.reportPublic FDA data

Aveta Smol Disposable Resecting Device, 2.9 mm

Primary DI
00850006759309
Brand
Aveta Smol Disposable Resecting Device, 2.9 mm
Company
MEDITRINA, INC.
Model
210-100
Catalog number
210-100
Device description
Aveta Smol Disposable Resecting Device, 2.9 mm, for use with Aveta System
Published
2020-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
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
00850006759347PackageGS13In Commercial Distribution
00850006759309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006759347008500067593478500067593470850006759347
00850006759309008500067593098500067593090850006759309

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.

Regulatory Flags#

DUNS number
080570262
Device count
1
Lot or batch
true
Expiration date on label
true

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
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07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
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