AccessGUDID - DEVICE: Lithotripsy Telescope bridge w.7Ch. working channel (EMAH3500915QL0)

GUDID

Device Identifier (DI) Information

Brand Name: Lithotripsy Telescope bridge w.7Ch. working channel
Version or Model: 35.009.15QL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35.009.15QL
Company Name: mahe medical gmbh

Primary DI Number: EMAH3500915QL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Lithotripsy Telescope bridge w.7Ch. working channel

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:	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?
37048	Footrest	A device intended to be used to sustain/retain a patient's foot or feet in a desired position. This device will often be considered an accessory to one or more parent devices. It is typically constructed of metal/plastic/rubber and can be attached to, e.g., operating tables/examination tables/treatment chairs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 5150b1e8-3c53-4c0c-bde0-c28a340950b7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 05, 2018