FDA.reportPublic FDA data

N/A

Primary DI
16973881680191
Brand
N/A
Company
Tianjin Newtrans Technology Development
Model
1003-C
Published
2023-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
26973881680181PackageGS1400In Commercial Distribution
16973881680191PrimaryGS10
06973881680170Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697388168018126973881680181
1697388168019116973881680191
06973881680170069738816801706973881680170

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.

Regulatory Flags#

DUNS number
527173399
Device count
200
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
26973881680198N/A1011-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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04580826926471PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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