AccessGUDID - DEVICE: V. Mueller (10885403013171)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU14320001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU14320001
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403013171
Issuing Agency: GS1
Commercial Distribution End Date: January 07, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller FARRIOR OVAL WINDOW EXCAVATOR & PISTON GAUGE, ANGLED SHAFT TIP 0.4MM DIAMETER, W/O NOTCH OVERALL LENGTH 5-7/8" (14.9CM)

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?
35915	Ear excavator	A hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYH	EXCAVATOR, EAR

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: f01bf457-26bc-4f13-9451-1a631b283247
Public Version Date: March 04, 2022
Public Version Number: 2
DI Record Publish Date: July 13, 2018