FDA.reportPublic FDA data

Hugo RAS

Primary DI
10884521850989
Brand
Hugo RAS
Company
Covidien LP
Model
MRASI0007
Device description
Extra Large Needle Driver
Published
2026-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10884521850989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185098910884521850989

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical needle holder, reusableA surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

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Primary DI, Brand, Company table
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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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