Spencer

Basic Information

• Brand Name: Spencer
• Primary DI: 08057711230396
• Version / Model: JM80007A BLUE SPLINT - STECC. RIGIDA GOMITO/CAVIGLIA cm 54
• Company Name: SPENCER ITALIA SRL
• Labeler DUNS: 442102067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-26
• Public Version: 1
• Public Version Date: 2023-11-03
• Public Version Status: New
• Public Device Record Key: 32a961d4-0e82-4d6c-9b5a-11622b6e1449

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62736	Medical device storage mount	A permanently-fixed structure upon which a medical device (not included) is designed to be mounted for storage purposes only; the device is not intended to be operated whilst mounted to this device. It is commonly wall-mounted and may be available in a variety of designs (e.g., wall bracket), may be dedicated to a specific type of device, or non-dedicated; it is not a shelf.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057711230396	GS1