Mediflex

Basic Information

• Brand Name: Mediflex
• Primary DI: 08904332600278
• Version / Model: 4005B-2
• Catalog Number: 4005B-2
• Company Name: ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
• Labeler DUNS: 872346468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 2
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 51804077-a898-46c2-b8d5-47decc3617f0

Device Description

Surgical Stays - 5 mm Blunt Hook 2 per pack Skin Hook, Small Blunt 2 per pack

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: Yes
• 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
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47821	Surgical retractor/retraction system blade, single-use	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08904332600285	GS1	Box	5	In Commercial Distribution
Primary	08904332600278	GS1
Unit of Use	08904332600346	GS1

Customer Contacts

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