FDA.reportPublic FDA data

Quinelato

Primary DI
07898506815289
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QS.807.26
Catalog number
QS.807.26
Device description
Quinelato amniotome 26cm
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HGEAmniotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGEAmniotomeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506815289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506815289078985068152897898506815289

GMDN Terms#

Term, Definition table
TermDefinition
Amniotome, reusableA surgical instrument used to cut/rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is long and shaft-like, and terminates in a sharp hook or protected blade used to rupture the membrane. It is typically made of high-grade stainless steel, and may be curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotic perforator or forceps and/or a trocar. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
899060826
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899798207462QuinelatoQD.938.102025-02-27
07899798207721QuinelatoQD.310.032025-02-27
07899798208858QuinelatoQX.926.182025-02-27
07899798208865QuinelatoQX.923.162025-02-27
07899798208872QuinelatoQX.922.222025-02-27
07899798208216QuinelatoQN.950.15QN.950.152025-01-03
07899798208223QuinelatoQX.927.00QX.927.002025-01-03
07899798208230QuinelatoQX.927.01QX.927.012025-01-03
07899798208247QuinelatoQX.924.19QX.924.192025-01-03
07899798208254QuinelatoQX.925.24QX.925.242025-01-03
07899798208261QuinelatoQX.921.19QX.921.192025-01-03
07899798208278QuinelatoQX.920.19QX.920.192025-01-03
07898506850297QuinelatoQO.996.03QO.996.032023-07-05
07899798207509QuinelatoQD.721.15QD.721.152024-04-15
07899798207530QuinelatoQD.724.25QD.724.252024-04-15
07899798207547QuinelatoQD.725.30QD.725.302024-04-15
07899798207585QuinelatoQB.301.01QB.301.012024-04-15
07899798207592QuinelatoQB.302.01QB.302.012024-04-15
07899798207608QuinelatoQB.302.02QB.302.022024-04-15
07899798207615QuinelatoQB.301.02QB.301.022024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047043737GimmiGimmi GmbHHGE2025-05-13
M803020301MedGyn Disposable Amnio HookMEDGYN PRODUCTS, INC.HGE2024-04-30
00849233010505BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
10849233010502BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
00840113231485Amnihook Amniotic Membrane PerforatorASPEN SURGICAL PRODUCTS, INC.HGE2023-02-27
00888937014761mityhookCoopersurgical, Inc.HGE2022-12-01
00749756166362DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
00749756166379DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166367DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166374DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
10767056096018Mabis DMID-M-S HOLDINGS, INC.HGE2021-05-19
00827002343122ObstiHookCOOK INCORPORATEDHGE2020-10-02
10827002343129ObstiHookCOOK INCORPORATEDHGE2020-10-02
H671AR1000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
H671AR2000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
04038653155002AESCULAPAesculap AGHGE2020-05-08
10381780506706Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
H8343022600Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
09350902000174AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24
09350902000211AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24