FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331135033
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7812-49
Catalog number
E7812-49
Device description
freeman areola marker, improved pattern, 38.0 mm diameter
Published
2022-11-10
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
00842331135033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331135033008423311350338423311350330842331135033

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
16931918101040AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918108414AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918152356AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918161327AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918172934AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
10080196771844MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312710MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312741MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
10198956206045CARDINAL HEALTHCardinal Health 200, LLCFZZ2025-11-07
00661392004511LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
00661392004528LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
10080196771851MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389025949MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389711798MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389362402MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-10
00754027700275RMAC SurgicalRMAC Surgical, IncFZZ2025-06-03
10080196326006MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-02
10198459271694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2025-02-23
00714646001290IsoMark™Bionix, LLCFZZ2025-02-20
10884389610312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-08-04
10080196031436Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-07-29
10197106628232CARDINAL HEALTHCardinal Health 200, LLCFZZ2024-05-07
10860010334574InkWell Health Inkwell Health LtdFZZ2023-12-14
10884389106358MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
20193489027218MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
10884389025925MedlineMEDLINE INDUSTRIES, INC.FZZ2023-10-13
00630094177267Bioseal Inc.BIOSEALFZZ2023-10-03
00630094177274Bioseal Inc.BIOSEALFZZ2023-10-03
10884389289280Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01
10884389289310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01