FDA.reportPublic FDA data

TRIGEN

Primary DI
00885556120095
Brand
TRIGEN
Company
Smith & Nephew, Inc.
Model
66800193
Catalog number
66800193
Device description
POWER CORD 125 VOLT 10 AMP - NORTH AMERICA (HOSPITAL GRADE)
Published
2015-09-28
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100107000SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0Smith & Nephew, Inc.2010-02-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556120095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556120095008855561200958855561200950885556120095

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power extension cableAn insulated electrical cord designed with a mains electricity supply plug at one end and single or multiple outlet socket clusters at the other end, intended to enable a connection between a medical device and a mains electricity supply. It is typically used where there is a need for many electrically-powered medical devices, e.g., in the operating room (OR). It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09