FDA.reportPublic FDA data

Orbital depressor, reusable

Definition
A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. This is a reusable device.
GUDID devices
59
Last updated
2026-08-12 10:12:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G223A1140970Medetz Surgical InstrumentsMedetz Surgical Instruments LLCA11-40972026-08-03
00190776420765MillenniumAvalign Technologies, Inc.92-H04642026-04-30
14026704801937PILLINGTELEFLEX INCORPORATEDIPN0205772022-12-08
14026704801944PILLINGTELEFLEX INCORPORATEDIPN0205782022-12-08
14026704801951PILLINGTELEFLEX INCORPORATEDIPN0205792022-12-08
G412DP20600MR PHACOCrestpoint Management LimitedDP20602025-05-27
04547451339212INAMIINAMI & CO., LTD.25R-0000822026-01-29
54026704801942PILLINGTELEFLEX INCORPORATEDIPN0205782022-12-08
54026704801959PILLINGTELEFLEX INCORPORATEDIPN0205792022-12-08
04547451339045InamiINAMI & CO., LTD.25R-0000692025-12-05
00757770524914Bausch + LombBausch & Lomb IncorporatedE60042025-08-08
00757770494156Bausch + LombBausch & Lomb IncorporatedE05232025-08-07
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHE10692025-07-11
00757770406685Bausch + LombBausch & Lomb IncorporatedE51072024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedE51052024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedE5100 102024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedE51082024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedE51062024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.10-38202024-10-15
00840516142470Anodyne SurgicalPsi/Eye-Ko, Inc.CX10012024-09-30
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.5-6211-082024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.5-6211-102024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.5-6211-122024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.5-62232024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.60-20002024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.60-20022024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.60-20092024-08-12
00887482111505Symmetry SchocketASPEN SURGICAL PRODUCTS, INC.60-20102024-08-12
00887482111529Symmetry O'Connor ASPEN SURGICAL PRODUCTS, INC.60-20122024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCBR42-328142024-06-03
54026704801935PILLINGTELEFLEX INCORPORATEDIPN0205772022-12-08
G586OP7131110Novo SurgicalNOVO SURGICAL, INC.OP7131-112023-12-18
G586OP7131120Novo SurgicalNOVO SURGICAL, INC.OP7131-122023-12-18
G586OP7131130Novo SurgicalNOVO SURGICAL, INC.OP7131-132023-12-18
03700483604333MORIAMORIA SAUrrets-Zavalia Marker2023-12-14
00190776355883MillenniumAvalign Technologies, Inc.3-510012X2023-11-17
00190776380359MillenniumAvalign Technologies, Inc.3-51062023-10-11
00190776355876MILLENNIUMAvalign Technologies, Inc.3-510010X2023-09-28
00190776355890MILLENNIUMAvalign Technologies, Inc.3-51082023-09-28
00190776355906MILLENNIUMAvalign Technologies, Inc.3-51072023-09-28
00883475953985Scleral DepressorCHARMANT INC.37-00832023-09-18
04547451337072INAMIINAMI & CO., LTD.23R-0000262023-08-24
G2231140960Medetz Surgical InstrumentsMedetz Surgical Instruments LLC11-40962023-08-10
B382SD9342911010Surgical DirectSurgical Direct, Inc.SD9342911012023-02-23
00190776367091MillenniumAvalign Technologies, Inc.3-51052023-02-22
00190776368463MillenniumAvalign Technologies, Inc.3-5100122023-02-22
00842331144738Novo Surgical Inc. NOVO SURGICAL, INC.OP7131-232022-11-11
00842331170744Novo Surgical Inc. NOVO SURGICAL, INC.OP7131-102022-11-13
B3561251050American MedicalsAmerican Medicals12022-09-27
05055313810261Duckworth & KentDUCKWORTH AND KENT LIMITED6-635-22022-08-31
05055313810278Duckworth & KentDUCKWORTH AND KENT LIMITED6-635-32022-08-31
05055313818823Duckworth & KentDUCKWORTH AND KENT LIMITED6-635-42022-08-31
05055313818939Duckworth & KentDUCKWORTH AND KENT LIMITED6-6152022-08-31
05055313827047Duckworth & KentDUCKWORTH AND KENT LIMITED6-615-12022-08-31
00840319726112Hayden MedicalHayden Medical, Inc.E3-21162022-08-16
00840319726129Hayden MedicalHayden Medical, Inc.E3-21172022-08-16
00840319726600Hayden MedicalHayden Medical, Inc.E3-45252022-08-16
G2231140970Orbital DepressorMedetz Surgical Instruments LLC11-40972022-08-08
08717872017266Kusaka Scleral Depressor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.10402020-11-16