FDA.report

Alcon, TurboSonics, Flared ABS, MicroTip

Primary DI
10380657408396
Brand
Alcon, TurboSonics, Flared ABS, MicroTip
Company
Alcon Laboratories, Inc.
Model
8065740839
Device description
30° Kelman®, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HQCUnit, phacofragmentation

Product Code Classifications

CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380657408396PackageGS16In Commercial Distribution
00380657408399PrimaryGS10

GMDN Terms

TermDefinition
Phacoemulsification system handpiece tip, single-useA device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.

Device Sizes

TypeValueUnit
Angle30degree
Outer Diameter0.9Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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