PurCel Labs Safety Insulin Pen Needles (32G x 4mm)

GUDID 10810143550402

Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).

Purcel Labs LLC

Autoinjector needle
Primary Device ID10810143550402
NIH Device Record Key6b78e987-9379-4e13-8e34-098e9b7e78c2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePurCel Labs Safety Insulin Pen Needles (32G x 4mm)
Version Model Number1086-100
Company DUNS127672531
Company NamePurcel Labs LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810143550405 [Primary]
GS100810143550467 [Package]
Contains: 00810143550405
Package: Inner Case [10 Units]
In Commercial Distribution
GS100810143550474 [Package]
Contains: 00810143550467
Package: Shipping Case [6 Units]
In Commercial Distribution
GS110810143550402 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-28
Device Publish Date2023-08-08

Devices Manufactured by Purcel Labs LLC

10810143550402 - PurCel Labs Safety Insulin Pen Needles (32G x 4mm)2023-08-28Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).
10810143550402 - PurCel Labs Safety Insulin Pen Needles (32G x 4mm)2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).
00810143550481 - PurCel Labs Safety Insulin Pen Needles (31G x 5mm)2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 31G x 5mm, (100/Box).
00810143550504 - PurCel Labs Safety Insulin Pen Needles (30G x 6mm)2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 30G x 6mm, (100/Box).
00810143550788 - PurCel Labs ASTM Level 1 Surgical Masks2023-08-28 ASTM Level 1 Surgical Masks, Non-Sterile, Single Use, Ear-loop, Blue, (50/Box).
00810143550801 - PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks2023-08-28 Individually Wrapped, ASTM Level 1 Surgical Masks, Non-Sterile, Single Use, Ear-loop, Blue, (50/Box).
00810143550580 - PurCel Labs Small 4 MIL Black Exam Gloves2023-08-23 Black Nitrile Exam Gloves, Size Small, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Ste
00810143550610 - PurCel Labs Medium 4 MIL Black Exam Gloves2023-08-23 Black Nitrile Exam Gloves, Size Medium, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-St
00810143550641 - PurCel Labs Large 4 MIL Black Exam Gloves2023-08-23 Black Nitrile Exam Gloves, Size Large, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Ste

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