FDA.reportPublic FDA data

VENTERA

Primary DI
00817470009521
Brand
VENTERA
Company
Smith & Nephew, Inc.
Model
420-20111
Catalog number
420-20111
Device description
VENTERA CANNULATED INSTRUMENT; ORANGE
Published
2015-12-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCRFLUORESCENT IMMUNOASSAY, TOBRAMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCRFluorescent Immunoassay, TobramycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121351000SINUS DILATION SYSTEMEntrigue Surgical, Inc.2012-08-29LRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817470009521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817470009521008174700095218174700095210817470009521

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus probeA hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931253VenSure Light Balloon Dilation SystemFiagon GmbHLCR2022-10-14
00380740154141AlinityABBOTT LABORATORIESLCR2018-12-12
00630414595962Atellica CH TobSiemens Healthcare Diagnostics Inc.LCR2017-12-22
00884883011328QMS Tobramycin Immunoassay Calibrator SetMicrogenics CorporationLCR2016-10-25
00842768005381Dimension® Flex® reagent cartridge TOBRSiemens Healthcare Diagnostics Inc.LCR2016-09-24
00842768015472Dimension Vista® Flex® reagent cartridge TOBRSiemens Healthcare Diagnostics Inc.LCR2016-09-24
00884883012691QMS Tobramycin AssayMicrogenics CorporationLCR2016-09-12
15099590222185SynchronBeckman Coulter, Inc.LCR2016-08-24
00380740013127ARCHITECTABBOTT LABORATORIESLCR2016-06-06