FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E90130100
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E90130-10
Catalog number
E90130-10
Device description
zenith fiber optic cable, for storz-compatible & male acmi
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
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E90130100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic retractor handleA hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgical sites typically during abdominal or pelvic surgical procedures. The fibreoptic bundle is attached to a separate light source, typically via a light-source cable, to produce illumination. 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
00190776417680MillenniumAvalign Technologies, Inc.EQH2026-03-04
00198506088841ELMED INCORPORATEDELMED INCORPORATEDEQH2026-02-23
00190776415716MillenniumAvalign Technologies, Inc.EQH2026-02-04
00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
00198506086786ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086854ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
00840183530679BR Surgical, LLCBR Surgical, LLCEQH2025-09-05
00190776408534MillenniumAvalign Technologies, Inc.EQH2025-08-19
00194613020132MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00194613123154MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00190776406769MillenniumAvalign Technologies, Inc.EQH2025-07-24
00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
00190776406172MillenniumAvalign Technologies, Inc.EQH2025-07-18
00198506084089ELMED INCORPORATEDELMED INCORPORATEDEQH2025-07-17
00190776402815MillenniumAvalign Technologies, Inc.EQH2025-06-30
00198506083716ELMED INCORPORATEDELMED INCORPORATEDEQH2025-06-23
00190776401474MillenniumAvalign Technologies, Inc.EQH2025-06-10
00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03
00198506083020ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28
00198506083037ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28
00198506082832ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-19
00190776394462MillenniumAvalign Technologies, Inc.EQH2025-05-07