AccessGUDID - DEVICE: SpiraBrush CX (00860275000309)

GUDID

Device Identifier (DI) Information

Brand Name: SpiraBrush CX
Version or Model: SBX-9000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SBX-9000
Company Name: HISTOLOGICS, LLC

Primary DI Number: 00860275000309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023001257 *Terms of Use

Device Description: SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.

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?
32679	Cervical cytology scraper, single-use	A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFB	Forceps, Biopsy, Gynecological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011488	000

Device Exempt from Premarket Submission: No 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: 1c44b40c-03f0-4a88-910e-55438bdb76fd
Public Version Date: November 11, 2019
Public Version Number: 4
DI Record Publish Date: September 28, 2016