FDA.reportPublic FDA data

Tricera™ Controller

Primary DI
00859273007014
Brand
Tricera™ Controller
Company
RELIGN CORPORATION
Model
R-10001
Catalog number
R-10001
Device description
System Controller with Footswitch
Published
2020-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162770000Relign SystemRelign Corporation2017-01-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592730070016PreviousGS10
00859273007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08592730070016085927300700168592730070016
00859273007014008592730070148592730070140859273007014

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver/electrosurgical system generatorA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(866) 608-0131customer.service@religncorp.com

Regulatory Flags#

DUNS number
080031617
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024681101STANDARD SHAVER™ 4.2MMR10029R100292025-10-07
008890246811184.2MM CURVED STANDARD SHAVER™R10030R100302025-10-07
00859273007052Dynablator™R-10005R-100052020-02-20
008592730070833-in-1 SHAVER™ 4.2mmR-10008R-100082020-07-17
00859273007120Standard Shaver 3.4mmR-10012R-100122021-03-05
008592730071443-in-1 SHAVER™ 5.0mmR-10014R-100142020-02-20
00859273007175Exoflow™R-10017R-100172020-02-20
00859273007243Curved Standard Shaver 3.4mmR-10024R-100242021-03-05
00859273007250Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
00859273007267Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16
00859273007274Curved Dynablator® XLR-10027R-100272024-12-18
00859273007212Standard Burr 5.0mmR-10021R-100212020-10-14
00859273007236Tricera™ Handpiece, AutoclavableR-10023R-100232020-08-20
00859273007021Tricera™ HandpieceR-10002R-100022020-02-20
00859273007038Veriflow™R-10003R-100032020-02-20
00859273007113Tricera™ Handpiece, AutoclavableR-10011R-100112020-02-20
10859273007271Curved Dynablator® XLR-10027R-100272024-12-18
10859273007257Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
10859273007264Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16
10859273007127Standard Shaver 3.4mmR-10012R-100122021-03-05

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Primary DI, Brand, Company table
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