AccessGUDID - DEVICE: AVID TruCustom (10809160051351)

GUDID

Device Identifier (DI) Information

Brand Name: AVID TruCustom
Version or Model: MAAH008-10_0004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVID MEDICAL, INC.

Primary DI Number: 10809160051351
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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
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: No
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: b2fb7915-5642-4974-90b8-7560fb13484a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20809160051358	3	10809160051351		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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