FDA.reportPublic FDA data

Novo Surgical

Primary DI
00842331190995
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OP7181-97
Catalog number
OP7181-97
Device description
mendez degree gauge, i.d. 12.0 mm
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
HLNGauge, lens, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLNGauge, Lens, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331190995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331190995008423311909958423311909950842331190995

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. 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
00810799037602Stephens InstrumentsKRISHNA IMPORTS INCHLN2020-09-22
00840159901106RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903148RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903919RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903926RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903933RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159905975RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159905982RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159905999RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159906002RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908549RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908556RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908563RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
06945033901990TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLN2018-09-24
06945033902003TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLN2018-09-24