FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331128103
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E8459-31
Catalog number
E8459-31
Device description
"laryngeal mirror, octagon handle, 8"" (20.3 cm), size 5, 20.0 mm"
Published
2022-11-09
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
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331128103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331128103008423311281038423311281030842331128103

GMDN Terms#

Term, Definition table
TermDefinition
ENT examination/treatment systemAn assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suction/blowing apparatus, equipment drawers, and a mirror heater.

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
04054462902880evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902910evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902934evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902941evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902958evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902972evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902989evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902996evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903061evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903078evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903085evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902767evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902774evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902781evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902798evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902804evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902811evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902828evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902835evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902842evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902859evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902866evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902873evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902897evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902927evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903009evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903016evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18