FDA.reportPublic FDA data

Good Neighbor Pharmacy

Primary DI
00087701432620
Brand
Good Neighbor Pharmacy
Company
Amerisourcebergen Drug Corporation
Model
10231717
Device description
5mm Pen Needle 100ct box
Published
2019-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K152410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100812000ULTICARE DISPOSABLE PEN NEEDLESUltimed, Inc.2010-06-03FMI
K152410000Top Fine Pen NeedleMedexel Co.,Ltd2016-02-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20087701432624PackageGS112In Commercial Distribution
00087701432620PrimaryGS10
00357515710130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2008770143262420087701432624
00087701432620000877014326200877014326200087701432620
00357515710130003575157101303575157101300357515710130

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.

Regulatory Flags#

DUNS number
007914906
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087701190810Good Neighbor Pharmacy103056022026-07-08
00087701190797good neighbor pharmacy7W92629C12026-06-01
00087701432699Good Neighbor Pharmacy611646102336602025-08-13
00087701432866Good Neighbor Pharmacy611646102336702025-08-13
00087701432910Good Neighbor Pharmacy611646102336802025-08-13
00087701432927Good Neighbor Pharmacy611646102336542025-08-13
00087701190667Good Neighbor PharmacySQN542025-03-03
20087701190661Good Neighbor PharmacySQN542025-03-03
00087701429477Good Neighbor90-3632024-09-26
00087701429484Good Neighbor90-3312024-09-26
30087701429478Good Neighbor90-3632024-09-26
30087701429485Good Neighbor90-3312024-09-26
00087701427404Good Neighbor90-50D2024-09-18
00087701427411Good Neighbor90-50K2024-09-18
00087701429491Good Neighbor90-3482024-09-18
00087701429989Good Neighbor90-55012024-09-18
00087701430145Good Neighbor90-3102024-09-18
00087701430152Good Neighbor90-5102024-09-18
30087701427405Good Neighbor90-50D2024-09-18
30087701427412Good Neighbor90-50K2024-09-18

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