FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E97325810
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E97325-81
Catalog number
E97325-81
Device description
"zenith gross ear spoon & hook, double ended, 4-3/4"" (12.0 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

Contact Domains#

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
G586E97325810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
G043615080BEARBear-Ent, LLCJYL2026-01-19
G043615090BEARBear-Ent, LLCJYL2026-01-19
G043615100BEARBear-Ent, LLCJYL2026-01-19
09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
04250676734891MENTIO disposable ear curette cottonSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250676734907MENTIO Disposable Nasal SpeculaSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250381821503Gillies skin hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676710017HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676711625ForkSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676705259Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676705266Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716071Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716088Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676738394HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676735560Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735577Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735584Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735591Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735607Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739582Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739599Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739605Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739612Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739629Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676745248Universal scissorsSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
00757770406265Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770406371Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770410125Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770412631Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05