FDA.report

Novo Surgical

Primary DI
G586N3764340
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
N3764-34
Catalog number
N3764-34
Device description
farabeuf raspatory, sharp, 13.0 mm wide, 6" (15.0 cm), light curve
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G586N3764340PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)860-6686info@novosurgical.com

Regulatory Flags

DUNS number
033029433
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810220800249Adler Instrument CompanyAdler, Inc.GAC2026-05-26
10705034577067N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577074N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577081N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577104N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577555N/ADEPUY SPINE, LLCGAC2026-02-05
03662663083577ActivLHighridge Medical, LLCGAC2026-02-03
00842078102275Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00842078102329Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00810207783558Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783565Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783572Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783589Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783596Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783602Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783619Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783626Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783633Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783640Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783657Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783664Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783671Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00190776411367MillenniumAvalign Technologies, Inc.GAC2025-09-22
00190776410445MillenniumAvalign Technologies, Inc.GAC2025-09-11
00190776409821MillenniumAvalign Technologies, Inc.GAC2025-09-08
00190776409920MillenniumAvalign Technologies, Inc.GAC2025-09-08
B356FF131030American MedicalsAmerican MedicalsGAC2025-08-16
B356FF131050American MedicalsAmerican MedicalsGAC2025-08-16
00190776406875MillenniumAvalign Technologies, Inc.GAC2025-07-24
00190776406578MillenniumAvalign Technologies, Inc.GAC2025-07-22