AccessGUDID - DEVICE: V. Mueller (10885403128394)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GU6389
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GU6389
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403128394
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: RETRIEVER 4FR 70CM 4WIRE BASKET 15MMSTRL

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:	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?
46452	Biliary/urinary stone retrieval basket, single-use	A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFL	DISLODGER, STONE, BASKET, URETERAL, METAL

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: Yes
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: 0f9dcd92-ba9d-4c14-bc04-49a0036b2077
Public Version Date: March 07, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016