FDA.reportPublic FDA data

DirectVision

Primary DI
00855308006038
Brand
DirectVision
Company
PERCUVISION LLC
Model
MA100059
Device description
DirectVision Visual Guide
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FGCUrethroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGCUrethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091600000DIRECTVISION GUIDE SYSTEMPercuvision, LLC2009-08-25FGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855308006038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855308006038008553080060388553080060380855308006038

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
015755434
Device count
1
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855308006007DirectVisionMA1002822016-09-23
00855308006014DirectVisionMA1001802016-09-23
00855308006045DirectVisionMA1001432016-09-23
10855308006004DirectVisionMA1002822016-09-23
10855308006011DirectVisionMA1001802016-09-23
00855308006021DirectVisionMA1002882016-09-23
10855308006042DirectVisionMA1001432016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551390153n.a.Karl Storz GmbH & Co. KGFGC2018-08-17
04048551075333n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551073681n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075272n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075296n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075319n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
00855308006021DirectVisionPERCUVISION LLCFGC2016-09-23
04042761077491OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077507OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077545OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077569OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077576OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077729OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21