FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331167089
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7213-77
Catalog number
E7213-77
Device description
novo myringotomy knife, 6 1/2" (16.5 cm), straight
Published
2022-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00842331167089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331167089008423311670898423311670890842331167089

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

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
00842331148354Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-12
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
04038653176366AESCULAPAesculap AGJYP2020-04-22
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180255022EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180250737EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250744EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250751EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250768EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250775EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250782EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180256357EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250928EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250935EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250942EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250959EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250966EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250973EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250980EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11