FDA.reportPublic FDA data

Quinelato

Primary DI
07898506811205
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.105.00
Catalog number
QD.105.00
Device description
Sternberg mouth gag
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506811205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506811205078985068112057898506811205

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
899060826
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
07899798207622QuinelatoQB.301.03QB.301.032024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783006858Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006865Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006872Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006889Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006896Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006902Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006926Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006933Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006940Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006957Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006964Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007282Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007305Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007312Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007336Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007343Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007350Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007367Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007381Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007404Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007411Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007428Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007442Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007459Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
G149TBS204S01TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSAS1208TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSG171800TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSLADY02TBS DentalACME ENTERPRISE.EMN2026-03-02
10889950145590Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-30
10889950145569Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-22