Lapbag

Basic Information

• Brand Name: Lapbag
• Primary DI: 08806182216626
• Version / Model: B11-1002
• Catalog Number: B11-1002
• Company Name: Sejong Medical Co., Ltd
• Labeler DUNS: 689850476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-06
• Public Version: 4
• Public Version Date: 2019-01-11
• Public Version Status: Update
• Public Device Record Key: cd7d05da-a57b-47cc-9421-8e93c148ad65

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: No
• Has Manufacturing Date: Yes
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45130	Tissue extraction bag	An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	88806182216622	GS1	CARTON	8	In Commercial Distribution
Package	18806182216623	GS1	INBOX	10	In Commercial Distribution
Primary	08806182216626	GS1
Package	78806182216625	GS1	CARTON	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K171726	000