LAPRA-TY

Basic Information

• Brand Name: LAPRA-TY
• Primary DI: 10705031206885
• Version / Model: XC200
• Catalog Number: XC200
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-25
• Public Version: 6
• Public Version Date: 2022-07-18
• Public Version Status: Update
• Public Device Record Key: 697afb4f-ae68-4db1-86a3-9c2e20316027

Device Description

Violet Polydioxanone Polymer, Synthetic Absorbable Suture Clips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZP	CLIP, IMPLANTABLE	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47018	Suture clasp, bioabsorbable	A small, sterile, implantable fastening device intended to be used to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. The device is typically made of a polymer (e.g., polydioxanone) that is gradually degraded and digested by body tissues; it is typically implanted with a dedicated applicator.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031206882	GS1	BOX	6	In Commercial Distribution
Primary	10705031206885	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K931492	000