LapPakOR

Basic Information

• Brand Name: LapPakOR
• Primary DI: 09349967000700
• Version / Model: W-18
• Catalog Number: W-18
• Company Name: THE O R COMPANY PTY LTD
• Labeler DUNS: 744346235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-23
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 7a2506bc-1f69-45c3-bfa1-8c54f95913db

Device Description

Single piece bowel retractor

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: Yes
• 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
GCZ	Retainer, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13371	Viscera retention paddle	A sterile, hand-held, flat device designed to be temporarily placed within a body cavity to retain and protect organs (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is in the form of a thin, flexible, synthetic polymer paddle that may have an attached cord that remains outside the body to assist in device removal prior to external wound closure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09349967000724	GS1	Shipper Box	6	In Commercial Distribution
Package	09349967000717	GS1	Outer Box	5	In Commercial Distribution
Primary	09349967000700	GS1