Tissue Retrieval pouch large

Basic Information

• Brand Name: Tissue Retrieval pouch large
• Primary DI: 05051223000655
• Version / Model: PS3401
• Catalog Number: PS3401
• Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED
• Labeler DUNS: 239403863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9145cdec-0981-4efe-92fa-2660a99e0ba4

Device Description

The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.

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
KGY	Bag, Intestine	General, Plastic Surgery	878.4100	1

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	55051223000650	GS1	shipping carton	50	In Commercial Distribution
Package	35051223000656	GS1	shelf box	10	In Commercial Distribution
Primary	05051223000655	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	500	Milliliter
Length	175	Millimeter
Width	125	Millimeter