AccessGUDID - DEVICE: FENIX (00855106005448)

GUDID

Device Identifier (DI) Information

Brand Name: FENIX
Version or Model: FIT-2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Torax Medical, Inc.

Primary DI Number: 00855106005448
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 137949538 *Terms of Use

Device Description: FENIX Introducer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34092	Anal sphincter prosthesis	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PMH	Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H130006	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06d1dded-8da4-479d-a741-689b02a09d91
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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