ClearPoint

Primary DI: 08503590070191
Brand: ClearPoint
Company: CLEARPOINT NEURO, INC.
Model: NGS-PD-03
Catalog number: NGS-PD-03
Device description: MR Neuro Drape Tapered w/Extension (GE)
Published: 2016-08-12
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: MR Safe
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Contact Domains

mriinterventions.com

Product Codes

Code	Name
ORR	Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Product Code Classifications

Code	Device	Specialty	Class
ORR	Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri	Neurology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
08503590070191	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
08503590070191	08503590070191	8503590070191

GMDN Terms

Term	Definition
Patient surgical drape, reusable	A noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a reusable device intended to be sterilized prior to use.

Term

Definition

Patient surgical drape, reusable

A noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	40 Degrees Fahrenheit	90 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

Phone	Email
949-900-6833	info@mriinterventions.com

Regulatory Flags

DUNS number: 959181160
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
00850047354716	ClearPoint	NGS-NC-09	NGS-NC-09	2026-03-10
00850047354693	ClearPoint	CP-SFL-VH-01	CP-SFL-VH-01	2026-02-16
00850047354686	ClearPoint	CP-SFL-01	CP-SFL-01	2026-02-13
00850047354082	ClearPoint	NGS-DS-06	NGS-DS-06	2025-05-21
00850047354099	ClearPoint	CP-SFW-11-30	CP-SFW-11-30	2025-02-05
00850047354136	ClearPoint	CP-WRK-WIN11	CP-WRK-WIN11	2025-02-05
00850047354105	SmartFlow	NGS-NC-01-EE	NGS-NC-01-EE	2024-11-25
00850047354112	SmartFlow	NGS-NC-02-EE	NGS-NC-02-EE	2024-11-25
00850047354051	ClearPoint Mobile Equipment Cart	CP-MEC-01	CP-MEC-01	2024-05-16
00850047354068	SMARTFrame Expanded Accessory Kit, 5 Fr	NGS-EAK-01-11-5	NGS-EAK-01-11-5	2024-05-16
00850047354075	SMARTFrame Expanded Accessory Kit, 7 Fr	NGS-EAK-01-11-7	NGS-EAK-01-11-7	2024-05-16
00850376007925	Bone Anchor	NGS-BA-01	NGS-BA-01	2024-05-16
00850047354006	SmartFrame OR	NGS-SFOR-DG-06	NGS-SFOR-DG-06	2024-03-11
00850047354013	SmartFrame OR	NGS-SFOR-SK-01	NGS-SFOR-SK-01	2024-03-11
00850047354020	SmartFrame OR	NGS-SFOR-SM-01	NGS-SFOR-SM-01	2024-03-11
00850047354037	SmartFrame OR	NGS-SFOR-DS-01	NGS-SFOR-DS-01	2024-03-11
00850047354044	SmartFrame OR	NGS-SFOR-BSF-01	NGS-SFOR-BSF-01	2024-03-11
00850376007932	SmartFrame OR	NGS-SFOR-XG-01	NGS-SFOR-XG-01	2024-03-11
00850376007949	SmartFrame OR	NGS-SFOR-CP-01	NGS-SFOR-CP-01	2024-03-11
00850376007956	SmartFrame OR	NGS-SFOR-DG-07	NGS-SFOR-DG-07	2024-03-11

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
00850376007758	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2022-01-31
00850376007598	SmartFrame Array	CLEARPOINT NEURO, INC.	ORR	2021-07-14
00850376007604	Array	CLEARPOINT NEURO, INC.	ORR	2021-07-14
00850376007628	Array	CLEARPOINT NEURO, INC.	ORR	2021-07-14
00850376007635	Array	CLEARPOINT NEURO, INC.	ORR	2021-07-14
00850359007744	ClearPoint Array	CLEARPOINT NEURO, INC.	ORR	2021-04-07
00850359007911	ClearPoint Array Workstation	CLEARPOINT NEURO, INC.	ORR	2021-04-07
00850359007959	SmartTip	CLEARPOINT NEURO, INC.	ORR	2021-04-07
00850359007072	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007089	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007096	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007102	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007119	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007126	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007133	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007140	SmartGrid	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007157	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007164	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007171	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007188	ClearPoint	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007195	ClearPoint	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007201	ClearPoint	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007218	ClearPoint	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007225	ClearPoint	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007232	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007249	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007256	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007263	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007270	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22
00850359007287	SmartFrame	CLEARPOINT NEURO, INC.	ORR	2021-01-22