FDA.reportPublic FDA data

Quinelato

Primary DI
07898506855193
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QX.309.08
Catalog number
QX.309.08
Device description
Curved Osteotome Quinelato, double guarded, 8mm
Published
2023-07-07
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
EMLChisel, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506855193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506855193078985068551937898506855193

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
00348783012316Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEML2026-04-02
00840018672505Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672666Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672970Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018674189Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018667396Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-10
00840018665682Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018666030Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018663732Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665491Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665507Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018661202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661226Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00194613013448MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013479MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013486MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
D92820001580BAUER GUARDED OSTEO 8MM STRW.H. Holden, Inc.EML2025-05-21
00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613104290MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613108601MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00888912126991DJO SURGICALEncore Medical, L.P.EML2024-08-22
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06