Wegman's Unifine Pentips Plus - 8mmx31G AN 3830WEG

GUDID 00761059832546

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

WEGMANS FOOD MARKETS, INC.

Autoinjector needle
Primary Device ID00761059832546
NIH Device Record Key732efaa9-a35d-4382-939a-8f80a709f1c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameWegman's Unifine Pentips Plus - 8mmx31G
Version Model NumberAN 3830WEG
Catalog NumberAN 3830WEG
Company DUNS059650069
Company NameWEGMANS FOOD MARKETS, INC.
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

Phone800-934-6267
Emailxx@xx.xx

Device Dimensions

Length8 Millimeter
Length8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100077890322581 [Primary]
GS100384703830001 [Unit of Use]
GS100761059831549 [Package]
Contains: 00077890322581
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059832546 [Package]
Contains: 00761059831549
Package: Case [24 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19