Pen Needle 320616

GUDID 50382903206181

PN 31G X 8MM 3B TW 50CT

Suzhou BD Medical Device Co., Ltd

Autoinjector needle
Primary Device ID50382903206181
NIH Device Record Keyd8c9259f-672b-4041-bab5-8b90c5967f31
Commercial Distribution StatusIn Commercial Distribution
Brand NamePen Needle
Version Model Number00681131386814
Catalog Number320616
Company DUNS420025124
Company NameSuzhou BD Medical Device Co., Ltd
Device Count50
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 Perscriptionfalse
OTC Over-The-Countertrue

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
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
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
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100681131386791 [Primary]
GS100681131386814 [Primary]
GS150382903206181 [Package]
Contains: 00681131386814
Package: Case [18 Units]
In Commercial Distribution
GS180382903206168 [Unit of Use]
GS180382903206182 [Unit of Use]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

On-Brand Devices [Pen Needle]

50382903206174PN RELION 31G X 6MM 3B TW 50CT
50382903206181PN 31G X 8MM 3B TW 50CT

Trademark Results [Pen Needle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEN NEEDLE
PEN NEEDLE
87159412 not registered Dead/Abandoned
Ko Pen Wang, MD
2016-09-02

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