FDA.reportPublic FDA data

Iris Hook, 1.0mm, Straight

Primary DI
08175700134019
Brand
Iris Hook, 1.0mm, Straight
Company
AURORA SURGICAL, LLC
Model
AS8-041
Catalog number
AS8-041
Device description
Iris Hook, 1.0mm, Straight
Published
2023-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNQHook, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08175700134019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08175700134019081757001340198175700134019

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
968368832
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08175700157001PunchesAS14-300AS14-3002024-03-11
08175700157018PunchesAS14-301AS14-3012024-03-11
08175700157025PunchesAS14-302AS14-3022024-03-11
08175700157032PunchesAS14-303AS14-3032024-03-11
08175700157049PunchesAS14-304AS14-3042024-03-11
08175700157506PunchesAS14-305AS14-3052024-03-11
08175700157513PunchesAS14-306AS14-3062024-03-11
08175700157520PunchesAS14-307AS14-3072024-03-11
08175700155670ProbesAS14-001TAS14-001T2024-02-06
08175700155687ProbesAS14-002TAS14-002T2024-02-06
08175700155694ProbesAS14-003TAS14-003T2024-02-06

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