FDA.reportPublic FDA data

Corneal marker, single-use

Definition
A 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.
GUDID devices
96
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810799039996Stephens InstrumentsKRISHNA IMPORTS INCSSD9 16012020-09-23
00845819000472Surgical Marking PenOASIS MEDICAL, INC.04422023-06-23
03700483602186ONEMORIA SAONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL2023-12-28
03700483611089ONEMORIA SAONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL2023-12-28
03700483611140ONEMORIA SAONE-BORES MARKER, 12MM2023-12-28
03700483611195ONEMORIA SAONE-BORES MARKER, 12MM2023-12-28
03700483612314ONEMORIA SAONE S- Corneal marker diameter 8mm X52023-12-29
03700483612369ONEMORIA SAONE S- Corneal marker diameter 8.5mm X52023-12-29
03700483612413ONEMORIA SAONE S- Corneal marker diameter 9mm X52023-12-29
03700483622672ONEMORIA SAONE S- Corneal marker diameter 8mm X102023-12-29
03700483622702ONEMORIA SAONE S- Corneal marker diameter 8.5mm X102023-12-29
03700483622733ONEMORIA SAONE S- Corneal marker diameter 9mm X102023-12-29
35056030402297Scleral MarkersSTERIMEDIX LIMITEDM7500-02/102024-10-07
55056030402291Scleral MarkersSTERIMEDIX LIMITED7500NS-02/100/Y2024-10-07
B382S34556140Surgical DirectSurgical Direct, Inc.S34556.142026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.S490.1002026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.S5616.022026-02-04
B382S345201000Surgical DirectSurgical Direct, Inc.S34520.1002025-12-10
B382SD9345561010Surgical DirectSurgical Direct, Inc.SD9345561012025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.SD934557102025-09-18
25056030402290Scleral MarkersSTERIMEDIX LIMITEDM7500-02/102024-10-07
45056030402294Scleral MarkersSTERIMEDIX LIMITED7500NS-02/100/Y2024-10-07
08403207009333Anmuth Medical InternationalAnmuth Medical International, LLC72-180-302025-02-12
08403207009340Anmuth Medical InternationalAnmuth Medical International, LLC72-181-162025-02-12
08403207009364Anmuth Medical InternationalAnmuth Medical International, LLC72-183-322025-02-12
B382S345411030Surgical DirectSurgical Direct, Inc.S34541.1032024-11-27
B382S345411020Surgical DirectSurgical Direct, Inc.S34541.1022024-10-14
G586E7811500Novo Surgical Inc. NOVO SURGICAL, INC. E7811-502022-11-14
03700483622689ONEMORIA SAONE S- Corneal marker diameter 8mm X52023-12-29
03700483622696ONEMORIA SAONE S- Corneal marker diameter 8mm X102023-12-29
03700483622719ONEMORIA SAONE S- Corneal marker diameter 8.5mm X52023-12-29
03700483622726ONEMORIA SAONE S- Corneal marker diameter 8.5mm X102023-12-29
03700483622740ONEMORIA SAONE S- Corneal marker diameter 9mm X52023-12-29
03700483622757ONEMORIA SAONE S- Corneal marker diameter 9mm X102023-12-29
03700483602193ONEMORIA SAONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL2023-12-28
03700483602223ONEMORIA SAONE-BORES MARKER, 12MM2023-12-28
03700483602230ONEMORIA SAONE-BORES MARKER, 12MM2023-12-28
03700483602582ONEMORIA SAONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL2023-12-28
B382S34500520Surgical DirectSurgical Direct, Inc.S34500.522023-12-21
B382S345472000Surgical DirectSurgical Direct, Inc.S34547.2002023-10-25
10845819000479Surgical Marking PenOASIS MEDICAL, INC.04422023-06-23
B382S34556400T0Surgical DirectSurgical Direct, Inc.S34556.400T2023-05-22
B382S60000000Surgical DirectSurgical Direct, Inc.S6000.0002023-04-24
B382SD934541100Surgical DirectSurgical Direct, Inc.SD934541102023-02-16
B382SD9S3455620T0Surgical DirectSurgical Direct, Inc.SD9S3455620T2023-02-16
B382SD9342911000Surgical DirectSurgical Direct, Inc.SD9342911002022-12-03
B382SD9345411010Surgical DirectSurgical Direct, Inc.SD9345411012022-12-03
B382SD9345411050Surgical DirectSurgical Direct, Inc.SD9345411052022-12-03
B382SD934547110Surgical DirectSurgical Direct, Inc.SD934547112022-12-03
B382SD934280140Surgical DirectSurgical Direct, Inc.SD934280142022-12-01
B382SD934500700Surgical DirectSurgical Direct, Inc.SD934500702022-12-01
B382SD9345201000Surgical DirectSurgical Direct, Inc.SD9345201002022-12-01
B382SD934543020Surgical DirectSurgical Direct, Inc.SD934543022022-12-01
B382SD9345431000Surgical DirectSurgical Direct, Inc.SD9345431002022-12-01
B382SD934550120Surgical DirectSurgical Direct, Inc.SD934550122022-12-01
B382SD934556120Surgical DirectSurgical Direct, Inc.SD934556122022-12-01
B382SD934556130Surgical DirectSurgical Direct, Inc.SD934556132022-12-01
B382SD934556140Surgical DirectSurgical Direct, Inc.SD934556142022-12-01
B382SD934556150Surgical DirectSurgical Direct, Inc.SD934556152022-12-01
B382S340161000Surgical DirectSurgical Direct, Inc.S34016.1002022-11-23
B382S342911000Surgical DirectSurgical Direct, Inc.S34291.1002022-11-23
B382S34500500Surgical DirectSurgical Direct, Inc.S34500.502022-11-23
B382S34500510Surgical DirectSurgical Direct, Inc.S34500.512022-11-23
B382S34500800Surgical DirectSurgical Direct, Inc.S34500.802022-11-23
B382S34500900Surgical DirectSurgical Direct, Inc.S34500.902022-11-23
B382S34541020Surgical DirectSurgical Direct, Inc.S34541.022022-11-23
B382S34547100T0Surgical DirectSurgical Direct, Inc.S34547.100T2022-11-23
B382S34556200T0Surgical DirectSurgical Direct, Inc.S34556.200T2022-11-23
B382S345562010Surgical DirectSurgical Direct, Inc.S34556.2012022-11-23
B382S345571000Surgical DirectSurgical Direct, Inc.S34557.1002022-11-23
B382S345581000Surgical DirectSurgical Direct, Inc.S34558.1002022-11-23
00842331177996Novo Surgical Inc. NOVO SURGICAL, INC.E7876-962022-11-14
00842331179723Novo Surgical Inc. NOVO SURGICAL, INC.E7940-272022-11-14
00842331182785Novo Surgical Inc. NOVO SURGICAL, INC.E97811-492022-11-14
00842331186462Novo Surgical Inc. NOVO SURGICAL, INC.E7811-572022-11-14
00842331186578Novo Surgical Inc. NOVO SURGICAL, INC.E7940-262022-11-14
00842331188626Novo Surgical Inc. NOVO SURGICAL, INC.OP7181-242022-11-14
00842331141621Novo Surgical Inc. NOVO SURGICAL, INC.E7811-562022-11-11
00842331150173Novo Surgical Inc. NOVO SURGICAL, INC.E7811-452022-11-12
00842331151866Novo Surgical Inc. NOVO SURGICAL, INC.E7811-472022-11-12