FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331181252
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N6946-61
Catalog number
N6946-61
Device description
"nicola micro pituitary instruments, bayonet shaft, malleable, 8 1/4"" (21.0 cm), curette, 6.5 mm ring, straight"
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
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331181252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331181252008423311812528423311812520842331181252

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

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
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
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10381780225447Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225454Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225638Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225393Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-09
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194378Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194385Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194392Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194408Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194415Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194422Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780167259Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780167273Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185505Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185536Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185543Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185550Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185604Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185628Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185666Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185673Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185697Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27