AccessGUDID - DEVICE: Endosee Advance Cannula with Pipet (60888937022003)

GUDID

Device Identifier (DI) Information

Brand Name: Endosee Advance Cannula with Pipet
Version or Model: ESPX5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 60888937022003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Endosee Advance Cannula with Pipet - 1 Kit - Contains - 1 Cannula and 1 Pipet Curet Endometrial Suction Curette 3mm OD

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:	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?
32655	Intrauterine cannula, single-use	A sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope And Accessories, Flexible/Rigid
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
No Device Sizes

Device Record Status

Public Device Record Key: 515be586-0eeb-4632-8f2e-7ba32c1cbfb6
Public Version Date: February 28, 2024
Public Version Number: 4
DI Record Publish Date: May 16, 2019