Silicone Sheeting Non-Reinforced

Basic Information

• Brand Name: Silicone Sheeting Non-Reinforced
• Primary DI: 00684995300293
• Version / Model: PR72034-015SPN
• Company Name: BENTEC MEDICAL OPCO, LLC
• Labeler DUNS: 080524654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-11
• Public Version: 5
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: f42b4bc9-5cd5-483f-9b5e-64afd9e3ca8f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
61557	Silicone-sheet tissue reconstructive material	A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00684995300293	GS1

Premarket Submissions

Submission Number	Supplement Number
K840172	000