FDA.reportPublic FDA data

AMNOTEC

Primary DI
04051423024520
Brand
AMNOTEC
Company
AMNOTEC International Medical GmbH
Model
72-410-00-US
Catalog number
72-410-00-US
Device description
VEQTRON 4K UHD Laparoscope, Ø 10 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
04051423024520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051423024520040514230245204051423024520

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
04051423017522AMNOTEC72-405-00-US72-405-00-US2023-08-18
04051423017539AMNOTEC72-405-30-US72-405-30-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

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Primary DI, Brand, Company table
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