FDA.reportPublic FDA data

AMNOTEC

Primary DI
04051423017522
Brand
AMNOTEC
Company
AMNOTEC International Medical GmbH
Model
72-405-00-US
Catalog number
72-405-00-US
Device description
VEQTRON 4K UHD Laparoscope, Ø 5.5 mm, 0°, WL. 310 mm, Autoclavable
Published
2023-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051423017522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051423017522040514230175224051423017522

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
342569940
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250942101402AMNOTEC71-068-05 NIR71-068-05 NIR2023-06-01
04250942104526AMNOTEC72-405-00 NIR72-405-00 NIR2023-11-13
04250942104533AMNOTEC72-405-30 NIR72-405-30 NIR2023-11-13
04250942104540AMNOTEC72-410-00 NIR72-410-00 NIR2023-11-13
04250942104557AMNOTEC72-410-30 NIR72-410-30 NIR2023-11-13
04051423017539AMNOTEC72-405-30-US72-405-30-US2023-08-18
04051423024520AMNOTEC72-410-00-US72-410-00-US2023-08-18
04051423024537AMNOTEC72-410-30-US72-410-30-US2023-08-18
06973031299924AMNOTEC71-182-30 NIR71-182-30 NIR2023-08-18
04250942120854AMNOTEC71-705-52 NIR TT71-705-52 NIR TT2023-06-16
04250942120861AMNOTEC71-705-4671-705-462023-06-16
04250942104519AMNOTEC71-182-30 NIR71-182-30 NIR2023-06-05
04250942120564AMNOTEC72-405-00-US72-405-00-US2023-06-05
04250942120571AMNOTEC72-405-30-US72-405-30-US2023-06-05
04250942120588AMNOTEC72-410-00-US72-410-00-US2023-06-05
04250942120595AMNOTEC72-410-30-US72-410-30-US2023-06-05
04250942120601AMNOTEC71-146-30 NIR C-US71-146-30 NIR C-US2023-06-05
04056634016593AMNOTEC71-705-4671-705-462023-08-18
04056634063269AMNOTEC71-705-52 NIR TT71-705-52 NIR TT2023-08-18
06973031299795AMNOTEC71-146-30 NIR C-US71-146-30 NIR C-US2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13