FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331177842
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7766-55
Catalog number
E7766-55
Device description
"freer septum chisel & gouge, straight, 6 1/4"" (15.9 cm), 4.0 mm wide"
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KANChisel, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KANChisel, NasalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331177842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331177842008423311778428423311778420842331177842

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

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
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
00810207783299Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
00810207783305Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
04250676731142ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731159ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731166ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731173ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731180ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731197ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731517ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676740540Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04250676740557Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04049047120520GimmiGimmi GmbHKAN2025-05-21
04049047121251GimmiGimmi GmbHKAN2025-05-21
04049047387459GimmiGimmi GmbHKAN2025-05-21
00887482146286Symmetry FreerASPEN SURGICAL PRODUCTS, INC.KAN2024-08-15
00888515236646BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236653BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236660BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236677BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236684BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236691BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
G586E3871130Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871140Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871150Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871160Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871170Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871190Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841400Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841450Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841480Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18