AccessGUDID - DEVICE: V. Mueller (10885403012488)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU19050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU19050
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403012488
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller SCHUKNECHT SPATULA 1.4MM WIDE, ANGLED 17DEG OVERALL LENGTH 6-1/4" (15.9CM)

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?
35346	Middle ear spatula	A hand-held manual surgical instrument designed to manipulate middle ear tissue or structures during ear/nose/throat (ENT) surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a flat blunt blade (no sharp edges) at the distal tip. Progressing from the handle to the distal tip the shaft or the blade may be straight, curved, or turn at various angles. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYL	HOOK, MICROSURGICAL 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: 0e9c3529-37c3-4dcd-af34-c5f0bcb9a423
Public Version Date: March 04, 2022
Public Version Number: 2
DI Record Publish Date: August 02, 2018