FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E333395FO0
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E3333-95FO
Catalog number
E3333-95FO
Device description
"biggs face lift retractor, w/ fiber optic light, 55.0 mm wide, 9"" (22.9 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586E333395FO0PrimaryHIBCC0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00192896123670Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00190776423902MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427443MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427450MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427467MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427474MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427481MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427498MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427504MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427511MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427528MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427535MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427658MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427702MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427719MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427726MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427818MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776420291MillenniumAvalign Technologies, Inc.GAD2026-08-25
G453FCE2004SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25
G453FCE2005SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25