FDA.report

Lacrimal Cannula 23Gx28 mm Straight

Primary DI
08058340226545
Brand
Lacrimal Cannula 23Gx28 mm Straight
Company
AKTIVE SRL
Model
1278
Catalog number
1278
Device description
Lacrimal Cannula 23Gx28 mm Straight
Published
2023-11-29
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
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08052276013415PrimaryGS10
08058340226545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08052276013415080522760134158052276013415
08058340226545080583402265458058340226545

GMDN Terms

TermDefinition
Lacrimal procedural cannulaA hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. 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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