Surgipro

Basic Information

• Brand Name: Surgipro
• Primary DI: 10884521176010
• Version / Model: SMHP-02
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-02
• Public Version: 7
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 3371aaa7-c0af-4b79-993b-6fc34a938489

Device Description

Mesh Hernia Patch

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

GMDN Terms

Code	Name	Definition	Implantable	Status
44756	Extra-gynaecological surgical mesh, composite-polymer	A partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. 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	20884521176017	GS1	CASE	3	In Commercial Distribution
Primary	10884521176010	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982575	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 130 Degrees Fahrenheit