Syneture

Basic Information

• Brand Name: Syneture
• Primary DI: 10884521161528
• Version / Model: US1589
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-03-24
• Public Version Status: Update
• Public Device Record Key: 6637989f-c73b-4a23-ab73-0a1d93172797
• Distribution End Date: 2019-04-29

Device Description

Custom Suture Pack,(2) 88863185-51;(1) 88863202-51;(3) CL-803;(1) GL-123;(1) S-608;(2) SC-5780G;(2) SN-776

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
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	20884521161525	GS1	CASE	5	Not in Commercial Distribution	2019-04-29
Primary	10884521161528	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 130 Degrees Fahrenheit