Syneture

Basic Information

• Brand Name: Syneture
• Primary DI: 10884521795488
• Version / Model: US1755
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 3
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: cb90f75a-0ca2-4ac7-bad3-f5a35c924554
• Distribution End Date: 2022-10-28

Device Description

Custom Suture Pack, (1) VP702MX, (1) VP902MX, (1) VP557MX, (3) 8886867901, (2) CL964, (1) CL843, (3) SM5637, (5) 8886325151, (2) GS62M, (1) S317, (1) S193, (1) S195, (1) GLS322, (1) 8886327131

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: No
• 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
13892	Suture kit, medicated	A collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. 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	20884521795485	GS1	CASE	6	Not in Commercial Distribution	2022-10-28
Primary	10884521795488	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit