FDA.reportPublic FDA data

Hugo RAS

Primary DI
10884521850859
Brand
Hugo RAS
Company
Covidien LP
Model
MRASC0001
Device description
Surgeon Console
Published
2026-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SCVModular electromechanical surgical system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCVModular Electromechanical Surgical SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250725000Hugo™ RAS SystemCovidien, LLC2025-12-03SCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521850859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185085910884521850859

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060548211356Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippeCMR SURGICAL LIMITEDSCV2026-03-18
05060548210731Versius Endoscope 0° (vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-11
05060548210229Versius Bedside Unit Cable (Short)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210366Versius Bedside Unit Cable (Long)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210526Versius Monopolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-10
05060548210724Versius Endoscope 30° (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210748Versius Camera Head (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210502Versius Bipolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210519Versius Bipolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210533Versius Monopolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548211226Versius Surgeon ConsoleCMR SURGICAL LIMITEDSCV2026-03-09
05060548211233Versius Instrument Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211240Versius Visualisation Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211257Versius Needle HolderCMR SURGICAL LIMITEDSCV2026-03-09
05060548211264Versius Bipolar Maryland GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211271Versius Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211288Versius Monopolar HookCMR SURGICAL LIMITEDSCV2026-03-09
05060548211295Versius Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211301Versius Monopolar Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211318Versius Insulating Sleeve AccessoryCMR SURGICAL LIMITEDSCV2026-03-09
05060548211325Versius Cadiere GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211332Versius Bipolar Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
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