FDA.reportPublic FDA data

Quinelato

Primary DI
07898506811601
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.196.01
Catalog number
QD.196.01
Device description
Malleable ribbon retractor 6,5mm x 20cm
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
KBLDepressor, Metal Tongue, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBLDepressor, Metal Tongue, SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506811601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506811601078985068116017898506811601

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
09348811004840INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
09348811004970INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
00190776407704MillenniumAvalign Technologies, Inc.KBL2025-08-01
00190776407711MillenniumAvalign Technologies, Inc.KBL2025-08-01
00194613046064MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049324MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049348MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049355MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049386MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049331MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00194613107178MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00841036058838N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073350N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073367N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00887482049150Symmetry Surgical®SYMMETRY SURGICAL INC.KBL2024-08-15
00840183517243BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183521714BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522858BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522865BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525422BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525736BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
G586E831252ES0Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312510Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312520Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98313210Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
00842331191930Novo Surgical Inc. NOVO SURGICAL, INC.KBL2023-12-07
00190776049034AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776049041AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776290283MILLENNIUMAvalign Technologies, Inc.KBL2023-09-28
00190776326456MILLENNIUMAvalign Technologies, Inc.KBL2023-09-28