FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E97327620
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E97327-62
Catalog number
E97327-62
Device description
"zenith day ear hook, small, 2.0 mm tip, 6-1/2"" (16.5 cm)"
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYLHook, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E97327620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
04054462906680evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906697evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906703evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906710evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906727evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906765evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906796evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906826evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907069evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907113evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907274evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907335evonosevonos GmbH & Co. KGJYL2026-08-21
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18