AccessGUDID - DEVICE: FlexGuard (04250341911572)

GUDID

Device Identifier (DI) Information

Brand Name: FlexGuard
Version or Model: 101 503 631
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LISA Laser Products GmbH

Primary DI Number: 04250341911572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315026396 *Terms of Use

Device Description: Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.

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?
60705	Laser lithotripsy fibre/suction guide	A sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy to function as a channel for insertion of the laser fibre of an endotherapy laser beam guide, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. It typically consists of a thin hollow tube inserted through a handle, which enable entry of the laser fibre and connection to vacuum tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070924	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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d439831-d580-4f81-8ebb-e08df9474729
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 21, 2018