ProdiGI

Basic Information

• Brand Name: ProdiGI
• Primary DI: 10884521808386
• Version / Model: ERD-TWSG
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-10
• Public Version: 10
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 9650e70b-d132-42e0-8cb1-238c83bd4900

Device Description

Secondary Grasper

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
QSW	Endoscopic Traction Device	Gastroenterology, Urology	876.4410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58096	Internally-anchored endoscopic retractor	A sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521808386	GS1
Package	20884521808383	GS1	CASE	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN220006	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 22 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry