AccessGUDID - DEVICE: Litho standard obturator for 35.009.10QL (EMAH3500920QL0)

GUDID

Device Identifier (DI) Information

Brand Name: Litho standard obturator for 35.009.10QL
Version or Model: 35.009.20QL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35.009.20QL
Company Name: mahe medical gmbh

Primary DI Number: EMAH3500920QL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Litho standard obturator for 35.009.10QL

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?
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	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: e3be61cd-55d6-49dc-a35a-083a96bae5f3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 03, 2016