FDA.reportPublic FDA data

Quinelato

Primary DI
07898506852406
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QW.851.26
Catalog number
QW.851.26
Device description
Parametrium Scissors cvd 26cm TC
Published
2023-01-11
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
HDKScissors, Episiotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506852406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506852406078985068524067898506852406

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. 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
04049047003205GimmiGimmi GmbHHDK2025-04-22
04049047003212GimmiGimmi GmbHHDK2025-04-22
04049047003229GimmiGimmi GmbHHDK2025-04-22
04049047679844GimmiGimmi GmbHHDK2025-04-22
04049047679851GimmiGimmi GmbHHDK2025-04-22
00840183526207BR Surgical, LLCBR Surgical, LLCHDK2024-03-28
G586OB6441260Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
G586OB96442290Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
00190776050337AvalignAvalign Technologies, Inc.HDK2023-09-28
00190776250621AvalignAvalign Technologies, Inc.HDK2023-09-28
07898506853847QuinelatoSchobell Industrial LtdaHDK2023-07-11
00190776250669AvalignAvalign Technologies, Inc.HDK2023-06-23
00840183513542BR Surgical, LLCBR Surgical, LLCHDK2023-04-14
14026704792105PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
54026704792103PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
00842331161261Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331167171Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331171772Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00887482024171Symmetry BraunASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039465Symmetry Braun-StadlerASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039472Symmetry WaldmannASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482018644Symmetry Bookwalter®ASPEN SURGICAL PRODUCTS, INC.HDK2022-08-23
00190660157180Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
00190660157197Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
04046826070595MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046826070618MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046955086597AESCULAPAESCULAP, INC.HDK2020-05-06
04038653042470AESCULAPAesculap AGHDK2020-04-20
04038653042487AESCULAPAesculap AGHDK2020-04-20
10381780500612Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18