AccessGUDID - DEVICE: Tricera™ Controller (00859273007014)

GUDID

Device Identifier (DI) Information

Brand Name: Tricera™ Controller
Version or Model: R-10001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R-10001
Company Name: RELIGN CORPORATION

Primary DI Number: 00859273007014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080031617 *Terms of Use

Device Description: System Controller with Footswitch

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52529	Arthroscopic shaver/electrosurgical system generator	A mains electricity (AC-powered) device designed to provide energy for a system designed to perform arthroscopic shaving (i.e., abrasion, resection, debridement of bone and soft tissue with a blade) and electrosurgical diathermy (i.e., the ablation and coagulation of soft tissue, as well as haemostasis of blood vessels, with an electrosurgical probe) during arthroscopic procedures on a joint. The unit typically consists of an operational display, operator controls, and software to help provide optimal parameters for the connected shaver handpiece(s) and electrosurgical probe(s). It may include an irrigation system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162770	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f11e31dc-c335-45f5-ad44-ff419e0941bf
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: February 20, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (866) 608-0131
Email: customer.service@religncorp.com

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