Extremity Care

Basic Information

• Brand Name: Extremity Care
• Primary DI: 00850003042244
• Version / Model: ALC200S
• Company Name: Extremity Care
• Labeler DUNS: 086365085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-13
• Public Version: 2
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: ade92419-ea2f-49e8-ba12-94410bc42bf2

Device Description

Cannula Kit Spatula w/Scalpel Kit Includes: Primary DI: 00850003042275 Version: ALC225 Device Description:Spatula Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11)

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: 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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1
GES	Blade, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46676	Tissue injection cannula	A thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.	No	Active
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850003042244	GS1

Customer Contacts

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