Identity
- Trade Name
- TroClear FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TC7 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- TC7 FDA UDI
- Primary DI / UDI-DI
- B606TC70 FDA UDI
- FDA Product Code
- NWV FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, single-use
TroClear by Mednium Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mednium Corporation
Sources (1)
- FDA UDI 34c7e17d-4277-4ca7-86a7-542bf71b5c53 36 fields · synced May 30, 2026