Altius Cuff Small

Primary DI: 00810118490071
Brand: Altius Cuff Small
Company: Neuros Medical, Inc.
Model: FG-600-001
Published: 2024-12-23
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: MR Unsafe
Rx: true
Sterile: true
Single use: true

Product Codes#

Code, Name table
Code	Name
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb	Unknown	3

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
P230020	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P230020	000	Altius® Direct Electrical Nerve Stimulation System	Neuros Medical, Inc.	2024-08-26	SAZ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00810118490071	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00810118490071	00810118490071	810118490071	0810118490071

GMDN Terms#

Term, Definition table
Term	Definition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection	An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 829526081
Device count: 1
Lot or batch: true
Serial number: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00810118490019	Altius Battery Charger	FG-603-000		2024-12-23
00810118490101	Altius IPG Accessory Kit	FG-610-000		2025-06-23
00810118490002	Altius IPG	FG-601-000		2024-12-23
00810118490026	Altius Patient Controller	FG-604-000		2024-12-23
00810118490057	Altius Programmer Wand	FG-606-000		2024-12-23
00810118490064	Altius Programming Application PC	FG-608-000		2024-12-23
00810118490088	Altius Cuff Medium	FG-600-002		2024-12-23
00810118490095	Altius Cuff Large	FG-600-003		2024-12-23

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00810118490101	Altius IPG Accessory Kit	Neuros Medical, Inc.	SAZ	2025-06-23
00810118490002	Altius IPG	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490019	Altius Battery Charger	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490026	Altius Patient Controller	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490057	Altius Programmer Wand	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490064	Altius Programming Application PC	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490088	Altius Cuff Medium	Neuros Medical, Inc.	SAZ	2024-12-23
00810118490095	Altius Cuff Large	Neuros Medical, Inc.	SAZ	2024-12-23