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
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

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