FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331167867
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7335-20
Catalog number
E7335-20
Device description
metal ear syringe, protecting shield tip, for metal ear syringes
Published
2022-11-13
Public version status
Update
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
KCPSyringe, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331167867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331167867008423311678678423311678670842331167867

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-accepting percutaneous/submucosal fluid injector, manual, professionalA hand-held, manually-powered mechanical device intended for use by a healthcare professional to accept a syringe (not included) for administering a percutaneous (e.g., intramuscular, subcutaneous) and/or submucosal injection of a medical fluid (e.g., medication, vaccine) to a patient; it is not dedicated to dental or intravenous applications. The device is typically a spring-loaded mechanical assembly in the form of a pistol or cylinder; the pharmaceutical is not included. 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
00842331167874Novo Surgical Inc.E7335-28E7335-282022-11-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.KCP2025-12-15
16971919460494Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-17
16971919460432Medi GradeNingbo Albert Novosino Co.,Ltd.KCP2025-11-11
00661392001855LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392010437LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392012486LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00661392027701LSL HEALTHCARELSL Industries, LLCKCP2025-10-30
00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00194613112639MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
00757770410651Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435401Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770435999Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00661392010444LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010451LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392010802LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392013414LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00661392045392LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010441LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010458LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392010809LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392013411LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
10661392045399LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
00370275092025FS Dispenser, StainlessForward Science Technologies LLCKCP2024-10-14
EDET031591mixing cannulas optima lilac 50 pcs.DETAX GmbHKCP2024-08-28
EDET031601mixing cannulas optima lilac 100 pcs.DETAX GmbHKCP2024-08-28
EDET041941mixing cannulas Automix 2 T-Mixer yellow 25 pcsDETAX GmbHKCP2024-08-28
00714646000576OtoClear Tip SampleBionix, LLCKCP2024-07-11
00840183511951BR Surgical, LLCBR Surgical, LLCKCP2024-06-10