FDA.reportPublic FDA data

ALCON

Primary DI
00380657409693
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

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

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658560270CLAREON VIVITY PROVNYWT0VNYWT0-0602026-11-02
00380658560287CLAREON VIVITY PROVNYWT0VNYWT0-0652026-11-02
00380658560294CLAREON VIVITY PROVNYWT0VNYWT0-0702026-11-02
00380658560300CLAREON VIVITY PROVNYWT0VNYWT0-0752026-11-02
00380658560317CLAREON VIVITY PROVNYWT0VNYWT0-0802026-11-02
00380658560324CLAREON VIVITY PROVNYWT0VNYWT0-0852026-11-02
00380658560331CLAREON VIVITY PROVNYWT0VNYWT0-0902026-11-02
00380658560348CLAREON VIVITY PROVNYWT0VNYWT0-0952026-11-02
00380658560355CLAREON VIVITY PROVNYWT0VNYWT0-1002026-11-02
00380658560362CLAREON VIVITY PROVNYWT0VNYWT0-1052026-11-02
00380658560379CLAREON VIVITY PROVNYWT0VNYWT0-1102026-11-02
00380658560386CLAREON VIVITY PROVNYWT0VNYWT0-1152026-11-02
00380658560393CLAREON VIVITY PROVNYWT0VNYWT0-1202026-11-02
00380658560409CLAREON VIVITY PROVNYWT0VNYWT0-1252026-11-02
00380658560416CLAREON VIVITY PROVNYWT0VNYWT0-1302026-11-02
00380658560423CLAREON VIVITY PROVNYWT0VNYWT0-1352026-11-02
00380658560430CLAREON VIVITY PROVNYWT0VNYWT0-1402026-11-02
00380658560447CLAREON VIVITY PROVNYWT0VNYWT0-1452026-11-02
00380658560454CLAREON VIVITY PROVNYWT0VNYWT0-1502026-11-02
00380658560461CLAREON VIVITY PROVNYWT0VNYWT0-1552026-11-02

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
00380657409709ALCONAlcon Laboratories, Inc.NKK2017-06-08
10380657409690ALCONAlcon 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