FDA.reportPublic FDA data

TroClear

Primary DI
B606TC10SPD1
Brand
TroClear
Company
Mednium Corporation
Model
TC10SPD
Catalog number
TC10SPD
Device description
Hospital SPD trocar squeegee cleaning system is a non-sterile multiple use per IFU medical device. TroClear SPD TM cleans debris inside the trocar canula, TroClear TM SPD squeegees the canula clean in a single pass. TroClear TM SPD can be rinsed clean and reused multiple times per IFU.
Published
2024-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B606TC10SPD6PackageHIBCC10In Commercial Distribution
B606TC10SPD7PackageHIBCC100In Commercial Distribution
B606TC10SPD1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
915-979-7562rbromley@mednium.com

Regulatory Flags#

DUNS number
080614210
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B606TC110TroClearTC11TC112024-09-12
B606TC50TroClearTC5TC52024-09-12
B606TC70TroClearTC7TC72024-09-12
B606TC80TroClearTC8TC82024-09-12
B606TC90TroClearTC9TC92024-09-12
B606TC10SPD6TroClearTC10SPDTC10SPD2024-09-12
B606TC116TroClearTC11TC112024-09-12
B606TC56TroClearTC5TC52024-09-12
B606TC76TroClearTC7TC72024-09-12
B606TC86TroClearTC8TC82024-09-12
B606TC96TroClearTC9TC92024-09-12

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Primary DI, Brand, Company table
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