FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586OP7125450
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OP7125-45
Catalog number
OP7125-45
Device description
dix needle & gouge, in reversible screw handle, complete set
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586OP7125450PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
08800268430111LYNKS Frontalis SlingLynk Solutec Inc.HNM2026-03-03
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011628McPherson Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011635Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011642Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011659Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011666Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011673Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011680Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011697Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011703Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011710Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011727Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011734Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011741Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011758Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011765Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011772Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011789Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011796Derf Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
G346EEN010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-07-07
G223112750WHMC0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G2231138500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G412PH10400MR PHACOCrestpoint Management LimitedHNM2025-06-03