FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586G4364710
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
G4364-71
Catalog number
G4364-71
Device description
wangensteen tissue forceps, tungsten carbide, 10" (25.4 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586G4364710PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
00846159039269SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039276SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039283SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039290SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039306SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039320SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039368SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039412SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039467SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039481SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039542SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26