FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586OP7191610
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OP7191-61
Catalog number
OP7191-61
Device description
mcintyre handpiece
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
HNNKnife, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586OP7191610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, reusableA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. 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
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
00850072675008MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675015MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675022MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675053MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675060MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675077MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675084MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675114MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675121MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675138MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675145MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675152MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675169MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675176MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675183MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675190MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675206MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675220MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16