FDA.reportPublic FDA data

Novo Surgical

Primary DI
00842331190902
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
G4353-54
Catalog number
G4353-54
Device description
gillies needle holder, tungsten carbide, offset design, curved, serrated jaws, 5-1/4" (13.3 cm)
Published
2023-12-18
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331190902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331190902008423311909028423311909020842331190902

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)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
00810220800171Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810220800188Adler Instrument CompanyAdler, Inc.MDM2026-05-26
06438394002678Activa InstrumentBioretec OyMDM2026-03-23
06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
00198506089619ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-17
00888867519459Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519473Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519503Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519510Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529755Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
00198506089510ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-13
00810158219236PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219243PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219250PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219281PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219304PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219311PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219359PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219373PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219007PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219014PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219021PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219038PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219069PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219090PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11