TroClear

Primary DI
B606TC116
Brand
TroClear
Company
Mednium Corporation
Model
TC11
Catalog number
TC11
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B606TC116PackageHIBCC10In Commercial Distribution
B606TC117PackageHIBCC10In Commercial Distribution
B606TC110PrimaryHIBCC0

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

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
B606TC10SPD6TroClearTC10SPDTC10SPD2024-09-12
B606TC56TroClearTC5TC52024-09-12
B606TC76TroClearTC7TC72024-09-12
B606TC86TroClearTC8TC82024-09-12
B606TC96TroClearTC9TC92024-09-12

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