FDA.reportPublic FDA data

ALCON

Primary DI
10380657409690
Brand
ALCON
Company
Alcon Laboratories, Inc.
Model
8065740969
Device description
SILICONE I/A TIP BENT
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKKNEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKKNeedle, Hypodermic, Single Lumen, ReprocessedGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380657409690PackageGS14In Commercial Distribution
00380657409693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065740969010380657409690
00380657409693003806574096933806574096930380657409693

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079C5020000450Golden Isles Pedicle Screw SystemIntelivation, LLCNKK2022-10-03
00850033297010Kova PlasticsAlltrista Plastics LLCNKK2021-07-29
00380657510122INTREPID®Alcon Laboratories, Inc.NKK2020-09-02
00380657510139INTREPID®Alcon Laboratories, Inc.NKK2020-09-02
00380658175016ULTRAFLOWAlcon Laboratories, Inc.NKK2018-02-28
00380657409693ALCONAlcon Laboratories, Inc.NKK2017-06-08
00380657409709ALCONAlcon Laboratories, Inc.NKK2017-06-08
10380657409706ALCONAlcon Laboratories, Inc.NKK2017-06-08
00380657517954ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07
00380658170011ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07
00380658172015ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07