FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E7214220
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E7214-22
Catalog number
E7214-22
Device description
austin chisel, 1.0 mm straight tip, 6 1/4" (16.0 cm)
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYECHISEL, MIDDLE-EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYEChisel, Middle-EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E7214220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear chiselA single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It 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. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument made of high-grade stainless steel. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770405220Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770409693Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770413140Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770417766Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770418695Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770424078Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770676439Bausch + LombBausch & Lomb IncorporatedJYE2025-08-05
00888515134157BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515228177BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229013BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229020BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229099BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230033BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230040BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230057BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230064BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
G586E7214730Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
00190776319052MillenniumAVALIGN TECHNOLOGIES, INC.JYE2023-06-23
00840343716868GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716875GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716882GEN2SURGIX MEDICAL LLCJYE2023-06-02
54026704805155PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
00840343700607Gen2SURGIX MEDICAL LLCJYE2022-10-18
00887482039755Symmetry Surgical®SYMMETRY SURGICAL INC.JYE2022-09-28
G277G2E9009630Gen2SURGIX MEDICAL LLCJYE2022-09-23
00190660008796Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008802Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008550Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04
00190660008819Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04
00190660009205Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04