CUSTOM HEALTHCARE SYSTEMS, INC

Basic Information

• Brand Name: CUSTOM HEALTHCARE SYSTEMS, INC
• Primary DI: 00811870034015
• Version / Model: JPK-19605
• Company Name: Manus Medical, LLC
• Labeler DUNS: 800604196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-20
• Public Version: 2
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 4521fa10-31d3-455e-a1a8-148a7f50ad59

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56303	Suture kit, non-medicated	A collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811870034019	GS1	N/A	50	In Commercial Distribution
Primary	00811870034015	GS1