FDA.reportPublic FDA data

IEC-Innoview GmbH

Primary DI
B192300054000
Brand
IEC-Innoview GmbH
Company
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
Model
30-0054-00
Catalog number
30-0054-00
Device description
2.7 mm, 30 deg. Cystoscope, l=302mm, autoclavable
Published
2016-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992983000BAHO AUTOCLAVABLE CYSTOSCOPEInnovative Endoscopy Components, LLC1999-10-07FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B192300054000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Length302Millimeter
Outer Diameter2.7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010741028
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B192300003000IEC-Innoview GmbH30-0003-0030-0003-002016-05-31
B192300004000IEC-Innoview GmbH30-0004-0030-0004-002016-05-23
B192300006000IEC-Innoview GmbH30-0006-0030-0006-002016-05-23
B192300008000IEC-Innoview GmbH30-0008-0030-0008-002016-05-23
B192300010000IEC-Innoview GmbH30-0010-0030-0010-002016-05-23
B192300011000IEC-Innoview GmbH30-0011-0030-0011-002016-05-24
B192300012000IEC-Innoview GmbH30-0012-0030-0012-002016-05-24
B192300055000IEC-Innoview GmbH30-0055-0030-0055-002016-05-24
B192300057000IEC-Innoview GmbH30-0057-0030-0057-002016-05-24
B192300068000IEC-Innoview GmbH30-0068-0030-0068-002016-07-12
B192300311000IEC-Innoview GmbH30-0311-0030-0311-002016-05-24
B192300346000IEC-Innoview GmbH30-0346-0030-0346-002016-05-24
B192300348000IEC-Innoview GmbH30-0348-0030-0348-002016-05-24
B192300421000IEC-Innoview GmbH30-0421-0030-0421-002016-05-24
B192300514000IEC-Innoview GmbH30-0514-0030-0514-002016-05-26
B192300515000IEC-Innoview GmbH30-0515-0030-0515-002016-05-26
B192300646000IEC-Innoview GmbH30-0646-0030-0646-002016-07-12
B1921091313550Eberle10-91313-5510-91313-552023-06-08
B192300048000IEC-Innoview GmbH30-0048-0030-0048-002023-06-08
B192300049000IEC-Innoview GmbH30-0049-0030-0049-002023-06-08

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Primary DI, Brand, Company table
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