Syneture

Basic Information

• Brand Name: Syneture
• Primary DI: 10884521742635
• Version / Model: US1735
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-04
• Public Version: 7
• Public Version Date: 2023-04-12
• Public Version Status: Update
• Public Device Record Key: 0d266b14-7d1d-4b32-a124-7b4a32ceb693
• Distribution End Date: 2022-10-28

Device Description

Custom Suture Pack, (4) 88862914-51, (2) CL-64-M, (1) CL-845, (1) CL-905, (1) CL-953, (2) CS-17-M, (2) GL-322, (1) S-317, (1) SL-5638, (2) VP-522-X, (1) VP-580-X, (1) VP-581-X, (1) VP-720-X, (2) VP-761-X

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: 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	20884521742632	GS1	CASE	6	Not in Commercial Distribution	2022-10-28
Primary	10884521742635	GS1

Customer Contacts

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

Storage Conditions

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