FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331165078
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7214-54
Catalog number
E7214-54
Device description
"hough-derlacki mobilizer, 4 pronged, 2.0 mm diameter, curved tip, 6"" (15.0 cm)"
Published
2022-11-13
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
KAJMobilizer, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAJMobilizer, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331165078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331165078008423311650788423311650780842331165078

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. 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
00757770406791Bausch + LombBausch & Lomb IncorporatedKAJ2026-02-11
00757770406838Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00757770436231Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00840183527495BR Surgical, LLCBR Surgical, LLCKAJ2024-11-26
00887482042472Symmetry HoughASPEN SURGICAL PRODUCTS, INC.KAJ2024-08-20
00190776044602AvalignAvalign Technologies, Inc.KAJ2023-09-28
00190776320263MillenniumAvalign Technologies, Inc.KAJ2023-06-23
14026704805522PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
54026704805520PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
00190660109691Ambler SurgicalAMBLER SURGICAL CORP.KAJ2021-01-04
10381780082439Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAJ2018-10-24
10885403010026V. MuellerSTERIS CORPORATIONKAJ2018-07-13
10885403009778V. MuellerSTERIS CORPORATIONKAJ2018-07-13