FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331167850
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7215-41
Catalog number
E7215-41
Device description
"mcgee oval window rasp, shaft angled 20 degrees, 6 1/2"" (16.5 cm), large, 0.7 mm diameter rasp"
Published
2022-11-13
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
JYYRasp, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYYRasp, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331167850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331167850008423311678508423311678500842331167850

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811112798INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-12-02
09348811112804INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-11-24
00757770420384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-05
00757770404384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770422722Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770435647Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00887482035160Symmetry WienerASPEN SURGICAL PRODUCTS, INC.JYY2024-08-12
00887482120057Symmetry WienerASPEN SURGICAL PRODUCTS, INC.JYY2024-08-12
00840183525958BR Surgical, LLCBR Surgical, LLCJYY2024-06-03
G586E7773430Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
G586E7773450Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
00190776324308MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324346MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324292MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776324339MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776376529AvalignAvalign Technologies, Inc.JYY2023-09-28
00810123201525Adler Instrument CompanyAdler, Inc.JYY2023-03-15
00840319742624Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742631Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742648Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742655Hayden MedicalHayden Medical, Inc.JYY2023-03-14
14026704807717PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807724PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807731PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807748PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807755PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807762PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807779PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807715PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807777PILLINGTELEFLEX INCORPORATEDJYY2022-12-08