Spartan Nash 1st Tier Unifine Pentips Plus

GUDID 00384703840003

Spartan Nash 1st Tier Unifine Pentips Plus - 4mm x 32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384703840003
NIH Device Record Keye529acd2-4d42-4d43-8efb-918e6dc0f28e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpartan Nash 1st Tier Unifine Pentips Plus
Version Model NumberAN 3840NF
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com

Device Dimensions

Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100041220520923 [Primary]
GS100384703840003 [Unit of Use]
GS100761059830658 [Primary]
GS100761059831655 [Package]
Contains: 00761059830658
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059832652 [Package]
Contains: 00761059831655
Package: Case [4 Units]
In Commercial Distribution
GS100761059840657 [Primary]
GS100761059841654 [Package]
Contains: 00761059840657
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059842651 [Package]
Contains: 00761059840657
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-08-05
Device Publish Date2020-09-18

On-Brand Devices [Spartan Nash 1st Tier Unifine Pentips Plus]

00761059851653Spartan Nash 1st Tier Unifine Pentips Plus - 5mm x 31G
00384703840003Spartan Nash 1st Tier Unifine Pentips Plus - 4mm x 32G
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