AccessGUDID - DEVICE: VCARE DX (30653405059824)

GUDID

Device Identifier (DI) Information

Brand Name: VCARE DX
Version or Model: 60-6080-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6080-000
Company Name: Conmed Corporation

Primary DI Number: 30653405059824
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2023
Device Count: 8
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: VCARE DX UTERINE MANIPULATOR/INJECTOR CANNULA

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?
58051	Uterine manipulator, single-use	A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	CANNULA, MANIPULATOR/INJECTOR, UTERINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093556	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75b1520c-21b7-4958-949a-30057fb68950
Public Version Date: March 07, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016