AccessGUDID - DEVICE: Flex-Ez Guidewire (M84934100)

GUDID

Device Identifier (DI) Information

Brand Name: Flex-Ez Guidewire
Version or Model: 3410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3410
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84934100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device

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":	Yes
For Single-Use:	Yes
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?
45623	General-purpose non-vascular guidewire	A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EYB	Catheter, Ureteral, Gastro-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K914358	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: c8bd7913-bf33-4b09-976a-b56b5c05c0c0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016