FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331174018
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7214-43
Catalog number
E7214-43
Device description
"guilford-wright flap knife, 2.0 mm x 5.0 mm blade, 6 3/4"" (17.0 cm)"
Published
2022-11-14
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
JYOKnife, Ear

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331174018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331174018008423311740188423311740180842331174018

GMDN Terms#

Term, Definition table
TermDefinition
Skin grafting knifeA hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. 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
04054462901937evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906390evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906406evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906413evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906420evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906437evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906444evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906451evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906468evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906475evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906536evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906543evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906581evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906598evonosevonos GmbH & Co. KGJYO2026-08-21
04054462900282evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901920evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901951evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901968evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906482evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906499evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906550evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906567evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906574evonosevonos GmbH & Co. KGJYO2026-08-18
04054462907533evonosevonos GmbH & Co. KGJYO2026-08-18
09348811109194INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811150257INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811109798INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-30
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11