FDA.reportPublic FDA data

Quinelato

Primary DI
07899798205246
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.751.01
Catalog number
QD.751.01
Device description
Double Langenbeck Retractor OMiQ
Published
2022-10-05
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
KADElevator, Ent
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899798205246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899798205246078997982052467899798205246

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
09348811101655INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
14026704742834PILLINGTELEFLEX INCORPORATEDKAD2025-01-15
14026704742841PILLINGTELEFLEX INCORPORATEDKAD2025-01-15
10381780539490MicroFrance®INTEGRA MICROFRANCEKAD2024-05-29
10381780539575MicroFrance®INTEGRA MICROFRANCEKAD2024-05-29
10381780539674MicroFrance®INTEGRA MICROFRANCEKAD2024-05-29
14026704742858PILLINGTELEFLEX INCORPORATEDKAD2024-01-10
14026704742865PILLINGTELEFLEX INCORPORATEDKAD2024-01-10
07898506816422QuinelatoSchobell Industrial LtdaKAL2023-01-09
07898506816446QuinelatoSchobell Industrial LtdaKAL2023-01-09
14026704790422PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704790439PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704790811PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704790828PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704790835PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704804624PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704804716PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704804723PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704804952PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704804969PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805386PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805546PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805614PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805638PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805645PILLINGTELEFLEX INCORPORATEDKAD2022-12-08
14026704805713PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704805720PILLINGTELEFLEX INCORPORATEDKAL2022-12-08
14026704805737PILLINGTELEFLEX INCORPORATEDKAL2022-12-08