FDA.reportPublic FDA data

TroClear

Primary DI
B606TC10SPD6
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B606TC10SPD7PackageHIBCC10In 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080614210
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B606TC10SPD1TroClearTC10SPDTC10SPD2024-09-12
B606TC110TroClearTC11TC112024-09-12
B606TC50TroClearTC5TC52024-09-12
B606TC70TroClearTC7TC72024-09-12
B606TC80TroClearTC8TC82024-09-12
B606TC90TroClearTC9TC92024-09-12
B606TC116TroClearTC11TC112024-09-12
B606TC56TroClearTC5TC52024-09-12
B606TC76TroClearTC7TC72024-09-12
B606TC86TroClearTC8TC82024-09-12
B606TC96TroClearTC9TC92024-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
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
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
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09421028490788PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
09421028491211PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10