FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331160509
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7890-41
Catalog number
E7890-41
Device description
"pitanguy flap demarcator, small, 5.0 mm wide, 6 1/4"" (15.9 cm)"
Published
2022-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331160509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331160509008423311605098423311605090842331160509

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@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
G42520103680My MedicalMy Medical Store LLCFZZ2026-02-26
G42520104020My MedicalMy Medical Store LLCFZZ2026-02-26
26931918101047AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918108411AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918152353AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918161324AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918172931AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
07540277010041RMAC SurgicalRMAC Surgical, IncFZZ2026-01-06
00860012465019FungalBlueToeFX IncFZZ2025-12-03
00194613019075MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613020842MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613022754MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613043643MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613046187MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613057039MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613088286MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094058MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094065MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613094072MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613107116MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613108496MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613121020MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123260MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123277MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
00194613123291MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
G2231523360Medetz Surgical InstrumentsMedetz Surgical Instruments LLCFZZ2025-06-30
10714646001129Sample: Opti-TattBionix, LLCFZZ2025-06-20
40080196771852MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389025940MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389711799MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12