FDA.reportPublic FDA data

Hugo RAS

Primary DI
10884521850996
Brand
Hugo RAS
Company
Covidien LP
Model
MRASI0010
Device description
Secure Cadiere Forceps
Published
2025-12-29
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
10884521850996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185099610884521850996

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical forceps, reusableA surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. 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
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

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Primary DI, Brand, Company table
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05060548211332Versius Bipolar Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
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