Custom Medical Specialties, Inc.

Basic Information

• Brand Name: Custom Medical Specialties, Inc.
• Primary DI: 00815849021853
• Version / Model: CMS-5896
• Company Name: CUSTOM ASSEMBLIES, INC.
• Labeler DUNS: 948904735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4283d36c-98eb-460f-832a-c9cbb0afca0d

Device Description

Label Pack - Sterile

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYV	Label Or Tag, Sterile	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43451	Sterility label/tag	A label or tag designed for use prior to, during, and after the process of sterilization of the device it has been attached to for the purpose of indicating that the sterility level required has been achieved. This label/tag can be designed with various built-in indicators that show if the sterility level has been reached or not, e.g., a change in the colour of the label/tag. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00815849021860	GS1		50	In Commercial Distribution
Primary	00815849021853	GS1