FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331135132
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N4322-91
Catalog number
N4322-91
Device description
"side wire/pin cutter, side cutting, tungsten carbide jaws, cuts up to .059"" (1.5 mm) diameter hard wire, 7"" (17.8 cm)"
Published
2022-11-10
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
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331135132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331135132008423311351328423311351320842331135132

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15
00841435124912TecometTECOMET INC.HXZ2025-09-05
00190776409432MillenniumAvalign Technologies, Inc.HXZ2025-09-02
10818674026298Knotless flush cutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-12
10818674025994Multi Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-11
00190776407766MillenniumAvalign Technologies, Inc.HXZ2025-08-01
00194613013912MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013929MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013936MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013943MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013950MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613015893MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01