AccessGUDID - DEVICE: V. Mueller (10885403279720)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: RH680-004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RH680-004
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403279720
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: NASAL SNARE WIRES 4GA (.014" DIA) CUT & FORMED PACKAGED BY THE GROSS

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:	Yes
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?
15676	Nasal snare, reusable	A hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZD	SNARE, 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: 3ac6810f-2772-4d70-bf40-4d523bc348b8
Public Version Date: December 11, 2019
Public Version Number: 2
DI Record Publish Date: September 14, 2018