FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586N6888430
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
N6888-43
Catalog number
N6888-43
Device description
"cone ventricular needles, w/ 2 holes, luer lock hub, 3 1/2"" (9.0 cm), 16 gauge"
Published
2023-12-18
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
HCDCannula, ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCDCannula, VentricularNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586N6888430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Premarket exempt
true
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
00840343727574Gen2SURGIX MEDICAL LLCHCD2026-04-23
00850047354716ClearPointClearpoint Neuro, Inc.HCD2026-03-10
00198506085031ELMED INCORPORATEDELMED INCORPORATEDHCD2025-09-05
00190776403003MillenniumAvalign Technologies, Inc.HCD2025-06-30
00190776401603MillenniumAvalign Technologies, Inc.HCD2025-06-11
00190776394325MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394332MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394356MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394363MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394370MillenniumAvalign Technologies, Inc.HCD2025-05-07
00198506056697ELMED INCORPORATEDELMED INCORPORATEDHCD2025-01-27
00198506056680ELMED INCORPORATEDELMED INCORPORATEDHCD2024-10-29
G586N688847C0Novo SurgicalNOVO SURGICAL, INC.HCD2024-10-15
00198506061356ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00198506061363ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00842180154018ELMEDELMED INCORPORATEDHCD2024-08-05
00198506060120ELMEDELMED INCORPORATEDHCD2024-07-23
00198506059568ELMEDELMED INCORPORATEDHCD2024-07-08
00198506058707ELMEDELMED INCORPORATEDHCD2024-07-05
00198506058325ELMEDELMED INCORPORATEDHCD2024-06-10
00842180199002ELMEDELMED INCORPORATEDHCD2024-04-23
00842180197855ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197862ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197879ELMEDELMED INCORPORATEDHCD2024-04-18
G586N6888300Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
G586N6888420Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
00842180179356ELMEDELMED INCORPORATEDHCD2023-10-05
00842180177253ELMEDELMED INCORPORATEDHCD2023-09-14
00190776373436MillenniumAvalign Technologies, Inc.HCD2023-06-23
00842180166936ELMEDELMED INCORPORATEDHCD2023-04-21