Lock-Stitch™ Procedure Kit

Basic Information

• Brand Name: Lock-Stitch™ Procedure Kit
• Primary DI: 00887868270376
• Version / Model: CM9500
• Catalog Number: CM-9500
• Company Name: CAYENNE MEDICAL, INC.
• Labeler DUNS: 606719685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 10
• Public Version Date: 2023-10-05
• Public Version Status: Update
• Public Device Record Key: d995ac39-d0ef-4a9d-abcf-3670b7822b43

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVN	Suture Kit	General, Plastic Surgery	878.4830	2

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
Primary	00887868270376	GS1

Customer Contacts

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