AccessGUDID - DEVICE: Medicon (04046826058227)

GUDID

Device Identifier (DI) Information

Brand Name: Medicon
Version or Model: 51.06.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51.06.00
Company Name: Medicon eG. Chirurgiemechaniker-Genossenschaft

Primary DI Number: 04046826058227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315492330 *Terms of Use

Device Description: set of 13 Bakes dilators 1-13mm

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?
35250	Common bile duct probe	A hand-held manual surgical instrument designed as a slender rod made of flexible metal with a blunt bulbous tip, used for exploring the common bile duct, i.e., the union of the cystic and hepatic ducts. It is used in surgical procedures to explore and/or dilate strictures of the common duct. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FGM	PROBE AND DIRECTOR, GASTRO-UROLOGY

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 42a4baad-0ccb-4f98-91bf-0c5266245780
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020