AccessGUDID - DEVICE: V. Mueller (10885403112843)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: RH1457
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RH1457
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403112843
Issuing Agency: GS1
Commercial Distribution End Date: September 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller PARKES HUMP GOUGE STRAIGHT OUTSIDE JAW 10MM WIDE OVERALL LENGTH 7" (17.8CM)

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?
35914	Nasal gouge	A single-bladed, hand-held manual surgical instrument designed to cut and shape the bone and cartilage of the nose during ear/nose/throat (ENT) surgery. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is typically made of high-grade stainless steel as a one-piece instrument and is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAQ	GOUGE, NASAL, ENT

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: 3b6645f4-eff2-46db-bf5c-cce8b498ebd4
Public Version Date: March 07, 2022
Public Version Number: 2
DI Record Publish Date: September 10, 2018