Freezer Ring

Basic Information

• Brand Name: Freezer Ring
• Primary DI: 08031497001999
• Version / Model: ASB0050
• Company Name: TECRES SPA
• Labeler DUNS: 435428396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: 3fde3e32-0218-46c9-87e5-a274a875ee55

Device Description

Freezer ring is an accessory intended to be applied to the syringe of Mendec Spine Kit. It allows a longer extrusion time of the resin.

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: 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47740	Orthopaedic cement-chilling device	A sterile device designed to be placed over an orthopaedic cement dispenser to cool the acrylic resin of orthopaedic cement to retard cement setting and extend cement extrusion and application time. It is typically made of plastic materials and usually consists of an open-ended tube that fits snugly over the body (barrel) of the cement dispenser after having been chilled in a refrigerator or freezer for a specified length of time. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08031497001999	GS1