AccessGUDID - DEVICE: UroFlex™B (03760187910130)

GUDID

Device Identifier (DI) Information

Brand Name: UroFlex™B
Version or Model: 211-0142
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MP-0011-URF
Company Name: MAUNA KEA TECHNOLOGIES

Primary DI Number: 03760187910130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 394136118 *Terms of Use

Device Description: No description.

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?
62288	Confocal endomicroscopy system probe	A minimally-invasive distal component of an endomicroscopy system intended to capture real-time images of microscopic cellular and tissue structures during an endoscopic procedure. It is a flexible fibreoptic bundle typically connected to a laser scanning unit that channels a laser beam to the anatomical site of interest and allows visualization by detecting the fluorescence emitted by the cells in the targeted region. This is a reusable device intended to be sterilized or disinfected prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWN	Confocal Optical Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132389	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Hydrogen Peroxide
High-level Disinfectant

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: cb113f03-f105-4e2a-81be-e85e889499fe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +33170080967
Email: support@maunakeatech.com

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