FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E93873750
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E93873-75
Catalog number
E93873-75
Device description
"zenith sheehan gouge, 6-1/4"" (16.0 cm), 4.0 mm wide"
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
KAQGOUGE, NASAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E93873750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal gougeA single-bladed, hand-held manual surgical instrument designed to cut and shape the bone and cartilage of the nose during ear/nose/throat (ENT) surgery. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is typically made of high-grade stainless steel as a one-piece instrument and is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. 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
00192896123007Alexander Mastoid GougeSONTEC INSTRUMENTS, INC.KAQ2026-03-31
00757770498956Bausch + LombBausch & Lomb IncorporatedKAQ2025-08-01
00190776392642MillenniumAvalign Technologies, Inc.KAQ2025-05-02
G586E3871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871840Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871850Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871860Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412490Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871760Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
00842962147665HNM MEDICALHNM STAINLESS, LLC.KAQ2023-04-07
00190776362232MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362249MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362256MillenniumAvalign Technologies, Inc.KAQ2023-02-22
M6335143910JEDMEDJEDMED INSTRUMENT COMPANYKAQ2023-02-03
00190776295189MillenniumAvalign Technologies, Inc.KAQ2022-12-12
00190776295196MillenniumAvalign Technologies, Inc.KAQ2022-12-12
00190776295202MillenniumAvalign Technologies, Inc.KAQ2022-12-12