FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331151866
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7811-47
Catalog number
E7811-47
Device description
freeman areola marker, standard pattern, 36.0 mm diameter
Published
2022-11-12
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
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
00842331151866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331151866008423311518668423311518660842331151866

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
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
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