FDA.reportPublic FDA data

N/A

Primary DI
26973881680198
Brand
N/A
Company
Tianjin Newtrans Technology Development
Model
1011-C
Published
2023-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
26973881680198PackageGS1400In Commercial Distribution
16973881680207PrimaryGS10
06973881680187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697388168019826973881680198
1697388168020716973881680207
06973881680187069738816801876973881680187

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527173399
Device count
200
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
false
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
16973881680153N/A1010-C2023-03-03
16973881680160N/A1007-E2023-03-03
16973881680177N/A1001-C2023-03-03
16973881680191N/A1003-C2023-03-03
16973881680207N/A1011-C2023-03-03
26973881680143N/A1010-C2023-03-03
26973881680150N/A1007-E2023-03-03
26973881680167N/A1001-C2023-03-03
26973881680181N/A1003-C2023-03-03
169738816800091009-C1009-C2023-01-12
169738816800782004-E2004-E2023-01-12
169738816800852002-E2002-E2023-01-12
169738816800922003-E2003-E2023-01-12
169738816801082005-E2005-E2023-01-12
169738816801151004-C1004-C2023-01-12
169738816801221005-C1005-C2023-01-12
169738816801391006-C1006-C2023-01-12
169738816801461008-C1008-C2023-01-12
06973881680026XinjingProWellness™1010-C2021-12-24
06973881680033XinjingProWellness™1009-C2021-12-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810929045699Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045705Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045712Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045729Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045736Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
01081092904567Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045665Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045696Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045702Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045733Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
006664161214969000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
006664161220119000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
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10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
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
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24