AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160046913
• Version / Model: WYMH008-07_0001
• Catalog Number: WYMH008-07
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: 95e39e71-bca2-45b5-bbd8-b5c3c1f8aaac
• Distribution End Date: 2018-08-22

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OKV	Obstetrical kit	Obstetrics/Gynecology	884.4520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34988	Birthing/delivery kit	A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160046910	GS1		2	Not in Commercial Distribution	2018-08-22
Primary	10809160046913	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]