Unifine Pentips Plus - 4mm x 33G AN3860

GUDID 00384703860032

For use with injectors for the subcutaneous injection of approved drugs, including insulin.

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

Primary Device ID	00384703860032
NIH Device Record Key	39c5a3b6-6897-4fca-aeb9-c9ba7543eaaa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Unifine Pentips Plus - 4mm x 33G
Version Model Number	AN3860
Catalog Number	AN3860
Company DUNS	803401454
Company Name	OWEN MUMFORD USA INCORPORATED
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	true

Customer Support Contacts

Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com
Phone	770-977-2226
Email	info@owenmumfordinc.com

Device Dimensions

Length	4 Millimeter
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter
Needle Gauge	33 Gauge
Length	4 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703860001 [Unit of Use]
GS1	00384703860018 [Primary]
GS1	00384703860025 [Package] Contains: 00384703860018 Package: Sleeve [6 Units] In Commercial Distribution
GS1	00384703860032 [Package] Contains: 00384703860025 Package: Case [24 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152339

FDA Product Code

FMI	Needle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-11-05
Device Publish Date	2018-10-03

On-Brand Devices [Unifine Pentips Plus - 4mm x 33G]

00384703860032	For use with injectors for the subcutaneous injection of approved drugs, including insulin.
00384700860912	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860813	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860714	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860639	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860516	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860417	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860318	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860233	For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860011	For use with injectors for the subcutaneous injection of approved drugs, including insulin