FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331171598
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
G1099-94
Catalog number
G1099-94
Device description
needle extension, 3" (7.6 cm)
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
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331171598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331171598008423311715988423311715980842331171598

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy needleA sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use 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
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLEW.H. Holden, Inc.GDM2026-01-15
04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
04059453124135Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-08-25
00810130455386Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00810130455393Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00194613120238MSI Precision Specialty InstrumentsMed Saver, Inc.GDM2025-08-01
00810130455300Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455317Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455324Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455331Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455218Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455225Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455232Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455164Medco ManufacturingMedco Manufacturing LLCGDM2025-06-17
00810130455140Medco ManufacturingMedco Manufacturing LLCGDM2025-06-10
00190776401139MillenniumAvalign Technologies, Inc.GDM2025-06-09
D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
00810130455003Medco ManufacturingMedco Manufacturing LLCGDM2025-05-06
00192896121492Heparin Olive Tip Needle CannulaSONTEC INSTRUMENTS, INC.GDM2025-04-22
00810130454976Medco ManufacturingMedco Manufacturing LLCGDM2025-04-04
00810130454907Medco ManufacturingMedco Manufacturing LLCGDM2025-03-27
00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
00819127023515Tulip Medical Products Reusable CannulasTulip Medical ProductsGDM2025-02-05
00810130454662Medco ManufacturingMedco Manufacturing LLCGDM2024-12-19
00810130454631Medco ManufacturingMedco Manufacturing LLCGDM2024-12-18
D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18