TroClear

Primary DI
B606TC50
Brand
TroClear
Company
Mednium Corporation
Model
TC5
Catalog number
TC5
Device description
Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Published
2024-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B606TC56PackageHIBCC10In Commercial Distribution
B606TC57PackageHIBCC100In Commercial Distribution
B606TC50PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
9159797562rbromley@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
B606TC10SPD1TroClearTC10SPDTC10SPD2024-09-12
B606TC110TroClearTC11TC112024-09-12
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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