FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586N6850570
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
N6850-57
Catalog number
N6850-57
Device description
"cervical axial micro knife blade, angled handle, 8-1/2"" (21.0 cm), 2.0 mm"
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
EMFKNIFE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586N6850570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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
08681506800343SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-26
08681506800350SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-24
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
04046826114374Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftEMF2025-12-01
00190776404604MillenniumAvalign Technologies, Inc.EMF2025-07-10
00190776403058MillenniumAvalign Technologies, Inc.EMF2025-07-01
00190776403201MillenniumAvalign Technologies, Inc.EMF2025-07-01
08717903490280Humeca Silver knifeHumeca B.V.EMF2025-05-20
08717903490297Humeca Humby knifeHumeca B.V.EMF2025-05-20
08717903490303Humeca Cobbett knifeHumeca B.V.EMF2025-05-20
08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
00190776393137MillenniumAvalign Technologies, Inc.EMF2025-05-05
04049047000143GimmiGimmi GmbHEMF2025-04-16
04049047000297GimmiGimmi GmbHEMF2025-04-16
04049047000303GimmiGimmi GmbHEMF2025-04-16
04049047000358GimmiGimmi GmbHEMF2025-04-16
04049047000365GimmiGimmi GmbHEMF2025-04-16
04049047000402GimmiGimmi GmbHEMF2025-04-16
04049047000426GimmiGimmi GmbHEMF2025-04-16
04049047000457GimmiGimmi GmbHEMF2025-04-16
04049047000549GimmiGimmi GmbHEMF2025-04-16
04049047000853GimmiGimmi GmbHEMF2025-04-16
04049047000860GimmiGimmi GmbHEMF2025-04-16
04049047000877GimmiGimmi GmbHEMF2025-04-16
04049047000884GimmiGimmi GmbHEMF2025-04-16