FDA.reportPublic FDA data

SlimLine

Primary DI
00821925009295
Brand
SlimLine
Company
Gyrus ACMI, LLC
Model
MRO-733A
Device description
SlimLine Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011849000MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSCircon Video2001-12-10FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925009295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925009295008219250092958219250092950821925009295

GMDN Terms#

Term, Definition table
TermDefinition
Rigid ureteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
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
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28