FDA.reportPublic FDA data

Scleral Depressors

Primary DI
08175700156110
Brand
Scleral Depressors
Company
AURORA SURGICAL, LLC
Model
AS14-102T
Catalog number
AS14-102T
Device description
O'Connor Scleral Depressor, Titanium
Published
2024-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNXDepressor, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08175700156110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700156110081757001561108175700156110

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
968368832
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08175700106733Mendez Degree GaugeAS2-0071TAS2-0071T2024-07-10
08175700106740Fixed CaliperAS2-012SAS2-012S2024-07-10
08175700106757Fixed CaliperAS2-012TAS2-012T2024-07-10
08175700106726Gimbel Mendez Beveled Degree Gauge, TitaniumAS2-011TAS2-011T2023-06-23
08175700106504Castroviejo Caliper, Stainless SteelAS2-001SAS2-001S2022-11-14
08175700106511Castroviejo Caliper, TitaniumAS2-001TAS2-001T2022-11-14
08175700106528Osher Internal Incision CaliperAS2-002AS2-0022022-11-14
08175700106535Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless SteelAS2-004SAS2-004S2022-11-14
08175700106542Braunstein Fixed Caliper (3.0mm-3.5mm), TitaniumAS2-004TAS2-004T2022-11-14
08175700106559Braunstein Fixed Caliper (3.5mm-4.0mm), Stainless SteelAS2-005SAS2-005S2022-11-14
08175700106566Braunstein Fixed Caliper (3.5mm-4.0mm), TitaniumAS2-005TAS2-005T2022-11-14
08175700106573Mendez Degree Gauge, Stainless SteelAS2-006SAS2-006S2022-11-14
08175700106580Mendez Degree Gauge, TitaniumAS2-006TAS2-006T2022-11-14
08175700106597Mendez Degree Gauge, Small SizeAS2-007TAS2-007T2022-11-14
08175700106603Grooved Mendez Degree GaugeAS2-008TAS2-008T2022-11-14
08175700106627Internal Micro Incision GaugesAS2-009AS2-0092022-11-14
08175700106634Beveled Mendez Degree Gauge, Stainless SteelAS2-010SAS2-010S2022-11-14
08175700106641Beveled Mendez Degree Gauge, TitaniumAS2-010TAS2-010T2022-11-14
08175700106658Stainless Steel RulerAS2-100AS2-1002022-11-14
08175700106719Helveston Scleral RulerAS2-101AS2-1012022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451339212INAMIINAMI & CO., LTD.HNX2026-01-29
04547451339045InamiINAMI & CO., LTD.HNX2025-12-05
04058935013394Depressor Scleral FlynnBausch & Lomb GmbHHNX2025-10-26
00757770483235Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770498765Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770500444Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770524914Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00194613011604MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613011628MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613109738MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
G412DP20600MR PHACOCrestpoint Management LimitedHNX2025-05-27
00194613119959MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-03-21
00757770406685Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.HNX2024-10-15
00757770426676Bausch + LombBausch & Lomb IncorporatedHNX2024-08-26
00887482049297Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNX2024-08-20
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
03700483602612ONEMORIA SAHNX2023-12-28