Safe-T-Surg

Basic Information

• Brand Name: Safe-T-Surg
• Primary DI: 10865082000167
• Version / Model: 2804-01-0001
• Company Name: BihlerMed, L.L.C.
• Labeler DUNS: 828549936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 1c9bf2c7-dd44-49a6-8631-f692307ac231

Device Description

Safe-T-Surg 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20865082000164	GS1	Box	4	In Commercial Distribution
Primary	10865082000167	GS1
Unit of Use	00865082000160	GS1

Customer Contacts

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