FDA.reportPublic FDA data

NA

Primary DI
04055207013724
Brand
NA
Company
Richard Wolf GmbH
Model
7325152
Catalog number
7325.152
Device description
FIBER-CHOLEDOCHOSCOPE Ø 2.5MM WL 450MM flexible, working channel Ø 1.2mm, TL 570mm, deflection +130°/-130°, glass fiber light cable, fiber image carrier, manual focus
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope and accessories, flexible/rigid
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207013724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207013724040552070137244055207013724

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic choledochoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique), or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length450Millimeter
Outer Diameter2.5Millimeter

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Ethylene Oxide;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
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
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02

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Primary DI, Brand, Company table
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04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
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00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
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