FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331148354
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7329-13
Catalog number
E7329-13
Device description
"buck myringotomy knife, 6 7/8"" (17.5 cm)"
Published
2022-11-12
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
JYPKnife, Myringotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYPKnife, MyringotomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331148354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331148354008423311483548423311483540842331148354

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
09421901970499Adept Medical Myringotomy KnifeADEPT MEDICAL LIMITEDJYP2024-03-20
G586E7213700Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
G586E7213780Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
00840183515966BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00840183515973BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00842331167089Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-13
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M6333814021ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
04038653176366AESCULAPAesculap AGJYP2020-04-22
05060180259037EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180259068EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180255022EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180252809EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252816EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252823EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252830EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252847EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252854EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252861EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252878EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252885EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252892EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252908EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11