PROLOOP

Basic Information

• Brand Name: PROLOOP
• Primary DI: 00650862309232
• Version / Model: 30923
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 8
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: d90f6589-3372-4a7c-83aa-15d55a35b11e
• Distribution End Date: 2019-12-31

Device Description

ProLoop Mesh XL, 1.6in. x 2.0in. (4.1cm x 5.0cm)

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 Safe
• 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
FTL	Mesh, surgical, polymeric	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60300	Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable	An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20650862309236	GS1		2	Not in Commercial Distribution	2019-12-31
Primary	00650862309232	GS1

Premarket Submissions

Submission Number	Supplement Number
K151437	000
K930669	000