FDA.reportPublic FDA data

Fixation Hooks

Primary DI
08175700135030
Brand
Fixation Hooks
Company
AURORA SURGICAL, LLC
Model
AS1-383
Catalog number
AS1-383
Device description
Twist Fixation Hook, Left
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08175700135030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700135030081757001350308175700135030

GMDN Terms#

Term, Definition table
TermDefinition
Eye muscle hook, reusableA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. 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

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