FDA.reportPublic FDA data

FENIX

Primary DI
00855106005448
Brand
FENIX
Company
Torax Medical, Inc.
Model
FIT-2
Device description
FENIX Introducer
Published
2016-02-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PMHMechanical Compression Device Fecal Incontinence (Non-Manually Operated)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMHMechanical Compression Device Fecal Incontinence (Non-Manually Operated)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H130006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H130006000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855106005448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855106005448008551060054488551060054480855106005448

GMDN Terms#

Term, Definition table
TermDefinition
Anal sphincter prosthesisA sterile device that functions as an artificial substitute for an anal sphincter intended to treat severe faecal incontinence (loss of control of the bowel). It is typically a fluid-filled implantable device made of silicone elastomer and consisting of tubing-connected components, including an occlusive cuff that fits around the anal canal, a pressure-regulating balloon, and a control pump. The patient regulates bowel evacuation by manually pumping fluid from the cuff to the balloon. This device is typically used in patients who have failed, or are not candidates for, less invasive forms of restorative therapy.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
137949538
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855106005219LINXLSSUSLSSUS2014-09-10
00855106005332LINXLXMC13LXMC132015-05-13
00855106005349LINXLXMC14LXMC142015-05-13
00855106005356LINXLXMC15LXMC152015-05-13
00855106005363LINXLXMC16LXMC162015-05-13
00855106005370LINXLXMC17LXMC172015-05-13
00855106005325LINX Reflux Management SystemLXMC122015-05-13
10855106005438ETHICON Linx Esophagus Sizing ToolLSTLST2020-12-23
30855106005432ETHICON Linx Esophagus Sizing ToolLSTLST2020-12-23
00855106005226LINX Esophagus Sizing ToolLSSUS2014-09-10
00855106005011LINXLS-[12]2014-09-10
00855106005028LINXLS-[13]2014-09-10
00855106005035LINXLS-[14]2014-09-10
00855106005042LINXLS-[15]2014-09-10
00855106005059LINXLS-[16]2014-09-10
00855106005066LINXLS-[17]2014-09-10
00855106005134LINXLXC-[12]2014-09-10
00855106005141LINXLXC-[13]2014-09-10
00855106005158LINXLXC-[14]2014-09-10
00855106005165LINXLXC-[15]2014-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855106005547FENIXTorax Medical, Inc.PMH2016-07-05
00855106005462FENIXTorax Medical, Inc.PMH2016-02-19
00855106005479FENIXTorax Medical, Inc.PMH2016-02-19
00855106005486FENIXTorax Medical, Inc.PMH2016-02-19
00855106005493FENIXTorax Medical, Inc.PMH2016-02-19
00855106005509FENIXTorax Medical, Inc.PMH2016-02-19
00855106005516FENIXTorax Medical, Inc.PMH2016-02-19
00855106005523FENIXTorax Medical, Inc.PMH2016-02-19
00855106005530FENIXTorax Medical, Inc.PMH2016-02-19