AccessGUDID - DEVICE: Hobbs Nasal Cytology Brush (M84942900)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Nasal Cytology Brush
Version or Model: 4290
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4290
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84942900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.

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":	Yes
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?
46388	General-purpose cytology brush	A sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEE	Brush, Biopsy, General & Plastic Surgery

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: ff134837-77f8-441f-b066-04510a8e57fe
Public Version Date: March 04, 2024
Public Version Number: 5
DI Record Publish Date: September 21, 2016