FDA.reportPublic FDA data

Quinelato

Primary DI
07898506828678
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QO.320.00
Catalog number
QO.320.00
Device description
Direct bond bracket holder tweezers
Published
2022-10-03
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
DZNInstruments, Dental Hand
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506828678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506828678078985068286787898506828678

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
06438311708775LMDentalLM-DentalDZN2026-05-25
06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
00348783008807Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783008890Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009552Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009569Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00840479202594RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
10840481136013BULK EZZest Anchors, LLCDZN2026-03-10
00840479201054COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201078COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201085COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27