AccessGUDID - DEVICE: LITHOCLAST (07613353062453)

GUDID

Device Identifier (DI) Information

Brand Name: LITHOCLAST
Version or Model: B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EL-046#A/005
Company Name: E.M.S. Electro Medical Systems S.A.

Primary DI Number: 07613353062453
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481233849 *Terms of Use

Device Description: Probe Ø 0,8 x 668 mm (2,4 Ch.)

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?
65261	Pneumatic lithotripsy system probe, urinary	A slender, metal, rod-like device intended to be attached to a pneumatic lithotripsy system handpiece to deliver pneumatically-created ballistic shock waves from an appropriate energy source to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation in situ. It is introduced endoscopically through a natural body orifice or surgically-made opening; it is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, Electro-Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012445	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: d0323cb3-4483-4ce0-9ef4-c72d78f3486d
Public Version Date: September 27, 2021
Public Version Number: 1
DI Record Publish Date: September 17, 2021