FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331190506
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
NSFE753K
Device description
clip yasargil, standard, temporary, 8.4 mm blade length
Published
2024-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCHClip, Aneurysm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331190506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331190506008423311905068423311905060842331190506

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysm clipA metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1877-860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603703679LAZICPeter Lazic GmbHHCH2025-10-30
04250603703778LAZICPeter Lazic GmbHHCH2025-10-30
04250603703860LAZICPeter Lazic GmbHHCH2025-10-30
04250603709527LAZICPeter Lazic GmbHHCH2025-08-07
04250603714835LAZICPeter Lazic GmbHHCH2025-08-07
04250603733911LAZICPeter Lazic GmbHHCH2025-08-07
04250603753018LAZICPeter Lazic GmbHHCH2025-06-30
04250603727194LAZICPeter Lazic GmbHHCH2025-06-16
04250603734031LAZICPeter Lazic GmbHHCH2025-06-16
04250603733980LAZICPeter Lazic GmbHHCH2025-05-13
04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
G586N697205A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N697206A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N6971710NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6971730NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6972700NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
04250603707424LAZICPeter Lazic GmbHHCH2024-09-12
04250603726791LAZICPeter Lazic GmbHHCH2024-03-25
04250603727057LAZICPeter Lazic GmbHHCH2024-03-25
00842331190513Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190520Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
04946329389340Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389357Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389364Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389371Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04250603703686LAZICPeter Lazic GmbHHCH2023-07-13