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Tricera™ Controller

FDA UDI

Class II (US FDA UDI)

by RELIGN Corporation

Identity

Trade Name
Tricera™ Controller FDA UDI
Generic Name
Arthroscopic shaver/electrosurgical system generator FDA UDI
Device Name
System Controller with Footswitch FDA UDI
Model / Reference
R-10001 FDA UDI
Description
System Controller with Footswitch FDA UDI

Identifiers

Catalog Number
R-10001 FDA UDI
Primary DI / UDI-DI
00859273007014 FDA UDI
510(k) Number
K162770 FDA UDI
FDA Product Code
HRX FDA UDI
GEI FDA UDI
GMDN Term
Arthroscopic shaver/electrosurgical system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Arthroscopic shaver/electrosurgical system generator

Tricera™ Controller by RELIGN Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K162770 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RELIGN Corporation

Sources (1)

  • FDA UDI f11e31dc-c335-45f5-ad44-ff419e0941bf 36 fields · synced Jun 9, 2026