FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E7749210
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E7749-21
Catalog number
E7749-21
Device description
"hajek-kofler sphenoid punch forceps, 6"" (15.2 cm) shaft, small solid biting jaws, 360 degree rotatable, 3.0 mm x 7.0 mm bite"
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
KAWPUNCH, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAWPunch, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E7749210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
00757770508570Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508587Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508594Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508600Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508631Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508648Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508662Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00840183530730BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00840183530747BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00194613011499MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029326MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029364MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047214MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047221MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613061739MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081393MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081447MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081508MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081560MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613085568MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613088842MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613091507MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613094720MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613095062MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102104MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102111MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613106171MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613123765MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00757770508563Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508624Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31