FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E7373630
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E7373-63
Catalog number
E7373-63
Device description
"citelli rongeur, 5 1/2"" (14.0 cm), #2, 2.5 mm x 4.0 mm serrated bite, shaft 8.5 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBBRONGEUR, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E7373630PrimaryHIBCC0

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

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Primary DI, Brand, Company table
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09348811146052INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811172921INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811145970INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
09348811172914INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
00757770404759Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770407071Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770411979Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770425396Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770428632Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770430925Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770469475Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00190776407056MillenniumAvalign Technologies, Inc.KBB2025-07-28
08403207006042Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
08403207006059Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
00842331191404Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
00190776044817AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776225421AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776044824AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044831AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044848AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048334AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048600AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776221102AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776320492MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320508MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320515MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320522MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28