FDA.reportPublic FDA data

Urology C-Arm Table-800, 230V

Primary DI
00879942070583
Brand
Urology C-Arm Table-800, 230V
Company
Mirion Technologies (capintec), Inc.
Model
058-805
Catalog number
058-805
Device description
The Urology C-Arm Table 800 is an ideal choice for urologic abdominal cavity image-guided procedures. The tabletop is cantilevered to accommodate portable or ceiling-suspended C-Arms and the wider front leg stance offers optimal patient access. The Urology C-Arm Table features motorized actuation of height, X-Y,lateral roll and Trendelenburg motions of the tabletop.
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00879942070583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00879942070583008799420705838799420705830879942070583

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table, poweredA powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-825-9500capintec@mirion.com

Regulatory Flags#

DUNS number
047684501
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859942006287CII Transporter0670-00070670-00072019-07-01
00859942006294CII Transporter II0670-20260670-20262019-07-01
008599420063002 cc Pin-Tec Syringe Shield4300-00604300-00602019-07-01
00859942006126Capintec Syringe Shield1 cc Pin-Tec Syringe Shield4300-00342018-11-28
00859942006133Capintec Syringe Shield3 cc PIn-Tec Syringe Shield4300-00352018-11-28
00859942006140Capintec Syringe Shield5 cc Pin-Tec Syringe Shield4300-00362018-11-28
00859942006157Capintec Syringe Shield10 cc Pin-Tec Syringe Shield4300-00372018-11-28
00859942006164Capintec Syringe Shield1 cc C-Tec Syringe Shield4300-00302018-11-28
00859942006171Capintec Syringe Shield3 cc C-Tec Syringe Shield4300-00312018-11-28
00859942006188Capintec Syringe Shield5 cc C-Tec Syringe Shield4300-00322018-11-28
00859942006195Capintec Syringe Shield10 cc C-Tec Syringe Shield4300-00332018-11-28
00859942006201Capintec Syringe Shield511 C-Tec Syringe Shield, 5 cc0665-20202018-11-28
00859942006218Capintec Syringe Shield511 C-Tec Syringe Shield, 10 cc0665-20152018-11-28
00859942006225Capintec Syringe Shield511 C-Tec Syringe Shield, 20 cc0665-20212018-11-28
00859942006263Capintec T-Vial ShieldT-Vial Shield0665-00022018-11-28
00879942070750MRI Stretcher240-100240-1002023-07-31
00879942070767MRI Stretcher with Fowler Positioning240-110240-1102023-07-31
00879942070644Ultra Pro Ultrasound Table, 230V058-725058-7252023-07-21
00879942070613Sound Pro Combination Ultrasound Table, 115V058-710058-7102023-07-14
00879942070620Sound Pro Combination Ultrasound Table, 230V058-715058-7152023-07-14

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