AccessGUDID - DEVICE: AVID TruCustom (10809160208946)

GUDID

Device Identifier (DI) Information

Brand Name: AVID TruCustom
Version or Model: UNVM146-04_0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UNVM146-04
Company Name: AVID MEDICAL, INC.

Primary DI Number: 10809160208946
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015623119 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
60655	Neovaginoplasty kit	A collection of non-sterile devices intended to be used during laparoscopic-assisted creation of a neovagina in the treatment of vaginal aplasia, whereby creation/expansion of the vaginal cavity is achieved through implantation of a tensioning thread attached at one end to an extra-abdominal tensioning device, and at the other end to a vaginal dilator situated at the vagina/vaginal dimple. It typically includes thread implantation guides, vaginal dilator(s), and the tensioning device. Post-surgical, daily tensioning is intended to create the neovagina. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OKV	Obstetrical kit

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: 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: f0828ac3-fd55-48a3-a9e4-ab5025050b3c
Public Version Date: November 26, 2018
Public Version Number: 1
DI Record Publish Date: October 25, 2018