ClearPoint

Basic Information

• Brand Name: ClearPoint
• Primary DI: 00850376007390
• Version / Model: CP-FFSMPL-02
• Catalog Number: CP-FFSMPL-02
• Company Name: Clearpoint Neuro, Inc.
• Labeler DUNS: 119078557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-22
• Public Version: 4
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: 2f4a200d-9141-4a07-82e5-c44449f41d79

Device Description

ClearPoint Multi-Positional Lower HFF Screws for Philips

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	882.4460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35446	Skull clamp	A U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device.	No	Active
35221	Stationary liquid oxygen container	An empty device designed as a large reservoir for the storage of liquid oxygen (LOX) prior to its distribution and use. It typically consists of a large capacity (e.g., 10 or 100 litres) double vessel bulk tank (i.e., an inner vessel to contain the liquid oxygen and an outer vessel for protection); vacuum in the space between both vessels provides thermal insulation for the LOX. The container typically includes evaporation coils that slowly boil the LOX into gas and is used in supply centres and in most large healthcare facilities before the distribution of LOX either as liquid or gas; some smaller containers are used at home to fill portable liquid oxygen units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850376007390	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091439	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 90 Degrees Fahrenheit