FDA.report

Fixation Ring with 10 Degree Marks, Nichamin Style

Primary DI
08175700105590
Brand
Fixation Ring with 10 Degree Marks, Nichamin Style
Company
AURORA SURGICAL, LLC
Model
AS1-356
Catalog number
AS1-356
Device description
Fixation Ring with 10 Degree Marks, Nichamin Style
Published
2022-11-14
Public version status
New
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

Contact Domains

Product Codes

CodeName
HNQHook, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08175700105590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08175700105590081757001055908175700105590

GMDN Terms

TermDefinition
Eyeball fixation instrument, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-727-821-3303info@aurorasurgical.com

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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08175700157551ProbesAS14-400AS14-4002024-07-10
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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