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Tricera™ Handpiece, Autoclavable

FDA UDI

Class II (US FDA UDI)

by RELIGN Corporation

Identity

Trade Name
Tricera™ Handpiece, Autoclavable FDA UDI
Generic Name
Arthroscopic shaver system handpiece, electrically-powered FDA UDI
Device Name
Shaver Handpiece, Autoclavable FDA UDI
Model / Reference
R-10023 FDA UDI
Description
Shaver Handpiece, Autoclavable FDA UDI

Identifiers

Catalog Number
R-10023 FDA UDI
Primary DI / UDI-DI
00859273007236 FDA UDI
510(k) Number
K162770 FDA UDI
FDA Product Code
GEI FDA UDI
HRX FDA UDI
GMDN Term
Arthroscopic shaver system handpiece, electrically-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
888.1100 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
MRI Safety
MR Unsafe FDA UDI

Category: Arthroscopic shaver system handpiece, electrically-powered

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

Similar devices

Also classified as Arthroscopic shaver system handpiece, electrically-powered.

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 f135b971-2bf0-4eb3-ba0e-fda810c16b9c 36 fields · synced Jun 9, 2026