FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E95686120
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E95686-12
Catalog number
E95686-12
Device description
zenith magill catheter introducing forceps, infant, 6-1/4" (16.0 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWBFORCEPS, TUBE INTRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWBForceps, Tube IntroductionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E95686120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
05010058179929InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-06-19
05010058179936InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-05-21
00888515023420BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023437BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023451BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
10653160369806CenturionCENTURION MEDICAL PRODUCTS CORPORATIONBWB2023-12-28
G58678TIF020Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF030Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF040Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95692280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693270Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
07898506813551QuinelatoSchobell Industrial LtdaBWB2023-07-07
07898506849307QuinelatoSchobell Industrial LtdaBWB2023-07-07
00190776055943AvalignAVALIGN TECHNOLOGIES, INC.BWB2023-06-23
05055382848769Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848783Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848806Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
00840183504052BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505042BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505189BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183511715BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
00840183519216BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
00842331185793Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-14
00842331167072Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13
00842331167751Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13
00842331171413Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13
00842331172090Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13
00842331141072Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-11
00842331132247Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-10