FDA.report

Irrigating Cystotome Ang.45° 27Gx16mm

Primary DI
08058340226668
Brand
Irrigating Cystotome Ang.45° 27Gx16mm
Company
AKTIVE SRL
Model
5050
Catalog number
5050
Device description
Irrigating Cystotome Ang.45° 27Gx16mm
Published
2023-12-19
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
HNYCystotome

Product Code Classifications

CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08052276012432PrimaryGS10
08058340226668Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08052276012432080522760124328052276012432
08058340226668080583402266688058340226668

GMDN Terms

TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, single-useA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. 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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