AccessGUDID - DEVICE: GYNECARE VERSAPOINT (10705031000926)

GUDID

Device Identifier (DI) Information

Brand Name: GYNECARE VERSAPOINT
Version or Model: 01931
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01931
Company Name: Ethicon Inc.

Primary DI Number: 10705031000926
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: Resectoscopic System, Working Element, Passive

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:	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?
35043	Electrosurgical handpiece/electrode holder, reusable	A device used to house or fix an active electrosurgical conducting unit (handpiece/pen with its electrode) when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. This device will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a reusable device intended to be sterilized prior to use.	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile, handle with care

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed084f9f-3283-437e-b050-896a5b5b14ec
Public Version Date: July 17, 2025
Public Version Number: 4
DI Record Publish Date: September 16, 2016