FDA.reportPublic FDA data

Virtuosaph Plus Endoscopic Vessel Harvester

Primary DI
00699753022966
Brand
Virtuosaph Plus Endoscopic Vessel Harvester
Company
Terumo Cardiovascular Systems Corporation
Model
VSP550
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160206000VirtuoSaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation2016-04-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753022961PackageGS15In Commercial Distribution
00699753022966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975302296150699753022961
00699753022966006997530229666997530229660699753022966

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Expiration date on label
true

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00699753538146Cardiovascular Procedure Kit787442026-10-09
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00699753538160Cardiovascular Procedure Kit787452026-10-09
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00699753537880Cardiovascular Procedure Kit788312026-08-26
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00699753537941Cardiovascular Procedure KitCX-UK770X2026-08-26
00699753537958Cardiovascular Procedure KitCX-UK7712026-08-26

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