FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586UR6105490
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
UR6105-49
Catalog number
UR6105-49
Device description
"stewart crypt hook, 9"" (23.0 cm), short hook"
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
FHBHOOK, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHBHook, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586UR6105490PrimaryHIBCC0

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
20193489104858MedlineMEDLINE INDUSTRIES, INC.FHB2024-04-25
30193489104855MedlineMEDLINE INDUSTRIES, INC.FHB2024-04-25
G586UR96105400Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
G586UR96105490Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
00190776303181MillenniumAvalign Technologies, Inc.FHB2023-11-16
00190776305116MillenniumAvalign Technologies, Inc.FHB2023-06-23
00842331159404Novo Surgical Inc. NOVO SURGICAL, INC.FHB2022-11-13
00192896075344PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-20
00192896020245PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020252PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020269PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
10885403050183V. MuellerSTERIS CORPORATIONFHB2018-08-30