AccessGUDID - DEVICE: V. Mueller (10885403129513)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: SU10982001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SU10982001
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403129513
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller BERENS COMMON DUCT SCOOP NO 1, SMALL SILVER PLATED OVERALL LENGTH 9" (22.9CM)

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?
46908	Gastro-urological scoop	A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. The device is typically made of high-grade stainless steel and has a malleable (bendable) distal tip to assist with accessibility to the various sites; it has a handle at the proximal end. The scoop is available in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHL	SCOOP

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: 41f02719-d656-4a4b-884e-29f5cff95d0e
Public Version Date: March 09, 2022
Public Version Number: 2
DI Record Publish Date: February 08, 2019