Kinray 1st Tier Unifine Pentips Plus

GUDID 00761059831198

Kinray 1st Tier Unifine Pentips Plus - 8mm x 31G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059831198
NIH Device Record Keyf978cb4a-bc48-4276-ada3-e34ae00db8ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinray 1st Tier Unifine Pentips Plus
Version Model NumberAN 3830KI
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

Device Dimensions

Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703830004 [Unit of Use]
GS100761059830191 [Primary]
GS100761059831198 [Package]
Contains: 00761059830191
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059832195 [Package]
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 [Kinray 1st Tier Unifine Pentips Plus ]

00761059891192Kinray 1st Tier Unifine Pentips Plus - 6mm x 31G
00761059851196Kinray 1st Tier Unifine Pentips Plus - 5mm x 31G
00761059841197Kinray 1st Tier Unifine Pentips Plus - 4mm x 32G
00761059831198Kinray 1st Tier Unifine Pentips Plus - 8mm x 31G
00761059820192Kinray 1st Tier Unifine Pentips Plus - 12mm x 29G

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