SUPERBAG

Basic Information

• Brand Name: SUPERBAG
• Primary DI: 10850013527646
• Version / Model: PNI2000
• Company Name: Dannik LLC
• Labeler DUNS: 117407001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-01-21
• Public Version: 1
• Public Version Date: 2023-01-30
• Public Version Status: New
• Public Device Record Key: 97a9b6a3-7730-40ce-81a8-bc6cf5935308

Device Description

PMI SuperBag 15 2XL Specimen Retrieval System, 2000mL

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
48026	Tissue extraction bag introducer	A sterile, hand-held, manual surgical instrument designed to introduce a folded tissue extraction bag into the patient's body through an appropriate access port during an endoscopic procedure. It is typically designed with a high-grade stainless steel stiff rod at the distal end around which the tissue extraction bag is folded and held in position with a gripping mechanism, e.g., prongs, and a handle at the proximal end. Once the bag is inside the body cavity, it is released and the introducer removed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850013527649	GS1
Primary	10850013527646	GS1