AccessGUDID - DEVICE: Cytuity™ (08714729986935)

GUDID

Device Identifier (DI) Information

Brand Name: Cytuity™
Version or Model: M0065907110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M0065907110
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729986935
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Cell Collection Catheter

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?
63730	Fallopian tube biopsy everting-balloon catheter	A sterile device intended to be inserted through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination. It consists of a slender tube with a linear everting (extending) balloon at the distal end, and a handle with controls at the proximal end. The balloon is pressurized prior to insertion into a hysteroscope and at the site of interest the balloon is extended into the fallopian tube where cells are collected on the balloon surface; the cells can then be placed into a transport medium for subsequent cytological examination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 34cm Length
Device Size Text, specify: 5F Diameter

Device Record Status

Public Device Record Key: f7dec977-8d6c-43e7-a6ff-9b6c3b06e2a0
Public Version Date: May 29, 2020
Public Version Number: 2
DI Record Publish Date: August 20, 2019