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

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
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
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