FDA.report

Set of 4 Iris Retractors

Primary DI
08058340220970
Brand
Set of 4 Iris Retractors
Company
AKTIVE SRL
Model
AK-0490
Catalog number
AK-0490
Device description
Set of 4 Iris Retractors
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HOCClip, Iris Retractor

Product Code Classifications

CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08052276027054PrimaryGS10
08058340220970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08052276027054080522760270548052276027054
08058340220970080583402209708058340220970

GMDN Terms

TermDefinition
Intraocular retractor, single-useA sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
433533053
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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