AccessGUDID - DEVICE: V. Mueller (10885403201103)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: MO11-84
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MO11-84
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403201103
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller EXCELLO-TYPE ELEVATOR NO. 84 OVERALL LENGTH 6" (15.2CM)

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?
35047	ENT elevator	A hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMJ	ELEVATOR, SURGICAL, DENTAL

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: 6c25bb07-8735-4ae7-bb8a-dafb944de946
Public Version Date: March 07, 2022
Public Version Number: 3
DI Record Publish Date: September 05, 2018