FDA.reportPublic FDA data

STERIS CleanGuide™

Primary DI
06936937792463
Brand
STERIS CleanGuide™
Company
Jiangsu Grit Medical Technology Co., Ltd.
Model
CG163
Device description
Disposable OTW Esophageal Dilators 16mm 48Fr
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNQDilator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936937792460PackageGS13In Commercial Distribution
26936937792467PackageGS127In Commercial Distribution
06936937792463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693693779246016936937792460
2693693779246726936937792467
06936937792463069369377924636936937792463

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Regulatory Flags#

DUNS number
554536935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936937792432STERIS CleanGuide™CG1332026-07-29
06936937792449STERIS CleanGuide™CG1432026-07-29
06936937792456STERIS CleanGuide™CG1532026-07-29
06936937792470STERIS CleanGuide™CG1732026-07-29
06936937792487STERIS CleanGuide™CG1832026-07-29
06936937792494STERIS CleanGuide™CG1932026-07-29
06936937792500STERIS CleanGuide™CG2032026-07-29
06936937786646STERIS CleanGuide™CG0532026-07-17
06936937792364STERIS CleanGuide™CG0632026-07-17
06936937792371STERIS CleanGuide™CG0732026-07-17
06936937792388STERIS CleanGuide™CG0832026-07-17
06936937792395STERIS CleanGuide™CG0932026-07-17
06936937792401STERIS CleanGuide™CG1032026-07-17
06936937792418STERIS CleanGuide™CG1132026-07-17
06936937792425STERIS CleanGuide™CG1232026-07-17
06936937798199Uro-Advantage120-18082026-04-30
06936937712997Single-Use Biopsy ForcepsRP-U-P16F2023-12-13
06936937713307Single-Use Biopsy ForcepsRP-U-P17F2023-12-13
06971890564634CONMED CleanGuideCG-15-12021-04-16
06971890564658CONMED CleanGuideCG-17-12021-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936937792432STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792449STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792456STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792470STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792487STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792494STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792500STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937786646STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792364STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792371STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792388STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792395STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792401STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792418STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792425STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15