Device
ProCureSafe Sterile Dual Safety Pen Needles 31g 3/16" 5mm - 100ea/bx 8bx/cs
Manufacturer
Twin Med, LLC
Twin Med, LLC
Model: PCSDPN500
Catalog: PCSDPN500
DI: 10840330705599
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: Yes
First Published: 2026-05-12
Current Version: 2026-05-20
Description
ProCureSafe Sterile Dual Safety Pen Needles 31g 3/16" 5mm - 100ea/bx 8bx/cs
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0b3c1b06-9690-4283-88ae-a49e1aefeafb
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
100
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
30840330705593
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
8
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330705599
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330705599
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00840330705592
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 44127
Name: Autoinjector needle
Definition:
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
FDA Product Codes
FMI
Needle, Hypodermic, Single Lumen
Premarket Submissions
Submission Number:
K253622
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Gauge
Item #1 - Size - @attributes - Value:
31
Item #1 - Size Type:
Needle Gauge
Item #2 - Size Text:
Needle is 5 mm long
Item #2 - Size Type:
Device Size Text, specify