FDA.reportPublic FDA data

Quinelato

Primary DI
07898506811595
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.195.00
Catalog number
QD.195.00
Device description
Wieder tongue depressor
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ECPInstrument, Ligature Tucking, Orthodontic
KBLDepressor, Metal Tongue, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1
KBLDepressor, Metal Tongue, SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506811595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506811595078985068115957898506811595

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, reusableA hand-held device intended to be used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make it less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a reusable device after appropriate cleaning.

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
G149TBSB1360TBS BASICSACME ENTERPRISE.ECP2026-05-20
G149TBSB1350TBS BASICSACME ENTERPRISE.ECP2026-05-18
10381780538547MicroFrance®INTEGRA MICROFRANCEKBL2024-05-29
006522211100533M™ Unitek™3M UNITEK CORPORATIONECP2022-12-08
006522211100603M™ Unitek™3M UNITEK CORPORATIONECP2022-12-08
006522212275533M™ Unitek™3M UNITEK CORPORATIONECP2022-12-08
006522212275603M™ Unitek™3M UNITEK CORPORATIONECP2022-12-08
00840326409312The Orthodontic StoreYoung Innovations, Inc.ECP2022-11-24
00840326409329The Orthodontic StoreYoung Innovations, Inc.ECP2022-11-24
00840326408766OrthoquestYoung Innovations, Inc.ECP2022-11-03
00843471101223The Orthodontic StoreYoung Innovations, Inc.ECP2022-11-01
00843471101230The Orthodontic StoreYoung Innovations, Inc.ECP2022-11-01
00843471101247The Orthodontic StoreYoung Innovations, Inc.ECP2022-11-01
D9098000011SPECTRUMOrtho Arch Company IncECP2022-09-17
D9098000021SPECTRUMOrtho Arch Company IncECP2022-09-17
D9098000061SPECTRUMOrtho Arch Company IncECP2022-09-17
D9098000141SPECTRUMOrtho Arch Company IncECP2022-09-17
D79819TIPS500TipsRELIANCE ORTHODONTIC PRODUCTS INCECP2021-02-12
00304040070482Henry ScheinHENRY SCHEIN, INC.ECP2021-01-31
10889950004019HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004026HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004033HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004095HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004118HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004125HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004132HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004149HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004156HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004170HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12
10889950004187HU-FRIEDYHU-FRIEDY MFG. CO., LLCECP2020-11-12