FDA.reportPublic FDA data

Single Use Angulation Knob Extender

Primary DI
06936603228937
Brand
Single Use Angulation Knob Extender
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-DEK-A
Catalog number
MAJ-2219
Device description
For Olympus 160/180/190 series endoscopesFor OLYMPUS EVIS EXERA (160 series), EXERA II (180 series), and EXERA Ill (190 series) endoscopes except CF-2T160, GIF-2T160, and GIF-2TH180
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603228934PackageGS110In Commercial Distribution
26936603228931PackageGS110In Commercial Distribution
06936603228937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660322893416936603228934
2693660322893126936603228931
06936603228937069366032289376936603228937

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle gripA device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device.

Regulatory Flags#

DUNS number
544375774
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936603230978Cleaning SpongeFTL-BCS-S1-BZSEN-3ECS2025-06-23
06936603225707Basic Bedside KitFTL-IPK-AM2BBK-12024-02-26
06936603225691Disposable Cleaning BrushFTL-CB-V12-IVB-12024-01-30
06936603227718HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
16936603227715HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
06936603231739Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
16936603228934Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
06936603226902Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
16936603226909Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
06936603210567Disposable Endoscopy Valve SetFTL-VS-PI20-A1152822024-03-08
06936603216460Disposable Endoscopy Adapter SetsFTL-VS-P-A1152922024-03-08
06936603216477Disposable Endoscopy Adapter SetsFTL-VS-P-B11152932024-03-08
06936603216491Disposable Endoscopy Adapter SetsFTL-VS-P-K11152942024-03-08
06936603224403Disposable Endoscopy Valve SetFTL-VS-PI20-B1152832024-03-08
06936603224410Disposable Endoscopy Valve SetFTL-VS-PI20-C1152842024-03-08
06936603227947Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
16936603227944Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
06936603230862Bedside Cleaning SpongeFTL-BCS-S1-BZ-WSEN-BK-12025-06-23
06936603230879Basic Bedside KitFTL-IPK-GSEN-BK-22025-06-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
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10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
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