Model: TRG001-000-000-001
DI: 00383790011839
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Hypodermic Needle 25G x 5/8"
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
adf3debd-e936-4975-a764-beb3f63e6b63
Distribution Status:
In Commercial Distribution
DUNS Number:
797372554
Device Count:
1
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
case
Item #1 - Device ID:
40383790011837
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5000
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00383790011839
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00383790011839
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 59230
Name: Hypodermic needle, single-use
Definition:
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
FDA Product Codes
FMI
Needle, Hypodermic, Single Lumen
Premarket Submissions
Submission Number:
K253047
Supplement Number:
000