FDA.reportPublic FDA data

Publix 6mm 32G PN

Primary DI
30041415100788
Brand
Publix 6mm 32G PN
Company
PUBLIX SUPER MARKETS, INC.
Model
317570
Device description
Publix 6mm 32G Pen needle
Published
2024-07-15
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

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100812000ULTICARE DISPOSABLE PEN NEEDLESUltimed, Inc.2010-06-03FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30041415100788PackageGS112In Commercial Distribution
20041415100781PrimaryGS10
00357515710147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3004141510078830041415100788
2004141510078120041415100781
00357515710147003575157101473575157101470357515710147

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006922009
Device count
100
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041415034747Publix9479022019-10-14
00041415318731PUBLIX84-35884-3582016-09-23
00041415319738PUBLIX84-3592016-09-24
00041415426733PUBLIX84-3752016-09-24
20041415101788Publix 3225452025-03-03
30041415017857Publix 3225452025-03-03
00041415055759PUBLIX Personal Lubricant7W92019-10-16
20041415100781Publix 6mm 32G PN3175702024-07-15
20041415098781Publix UltiGuard2998192024-07-01
20041415099788Publix UltiGuard2999262024-07-01
30041415098788Publix UltiGuard2998192024-07-01
30041415099785Publix UltiGuard2999262024-07-01
20041415318735PUBLIX84-35884-3582016-09-23
20041415319732PUBLIX84-3592016-09-24
20041415426737PUBLIX84-3752016-09-24
00041415095786PublixBP3GX1-4BPBX2023-08-10
00041415096769PublixOne Step Pregnancy Test2020-01-28
00041415024762Publix One Step Pregnancy TestFPPL2016-08-10
00041415031784Publix AutoletAT 0274PX2023-06-23
00041415032781Ultra Thin LancetsAT 0565PX2023-06-23

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08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27