AccessGUDID - DEVICE: VCM 50 (00856589007059)

GUDID

Device Identifier (DI) Information

Brand Name: VCM 50
Version or Model: VCM-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KRONNER PROTOTYPES, INCORPORATED

Primary DI Number: 00856589007059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 091301184 *Terms of Use

Device Description: For supporting the vagina during laparoscopic vaginal procedures. 50 mm width, inserted end.

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):	No
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?
13392	Vaginal retractor, self-retaining	A self-locking, surgical instrument, used for separating the edges of the vagina and holding back the tissue allowing a surgical intervention or examination. The instrument may resemble a large pair of scissors or have an open circle design with pointed, blunted, or wire-like blades or claws that grasp and part the tissue of the vaginal opening. It is typically made of stainless steel and comes in a variety of designs. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HDL	Retractor, Vaginal

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c118b2da-f6ac-4d5f-8666-002fe282e5da
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 26, 2017