Surgidac

Basic Information

• Brand Name: Surgidac
• Primary DI: 10884521129443
• Version / Model: 173023
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-03-07
• Public Version Status: Update
• Public Device Record Key: 3a186a33-8fb8-45d9-a28e-86580ff80f83

Device Description

Polyester Single Stitch Reload

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
OCW	Endoscopic tissue approximation device	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47462	Suture knot-tying device	A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521129440	GS1	CASE	12	In Commercial Distribution
Primary	10884521129443	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934738	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			diameter,2/0,N/A;
Length	48	Inch

Storage Conditions

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