FDA.reportPublic FDA data

Quinelato

Primary DI
07898506815197
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QS.630.28
Catalog number
QS.630.28
Device description
Collin vaginal specula n° 1
Published
2023-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506815197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506815197078985068151977898506815197

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440096Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440102Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440119Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440126Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440133Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440164Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440324Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440331Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440348Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440355Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440362Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440379Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26