Model: 6981
DI: 00616784698120
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2019-05-06
Current Version: 2026-05-28
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
6
Record Key:
3c3200e9-7b31-421b-9386-0c5fd8309c58
Distribution Status:
In Commercial Distribution
DUNS Number:
008124539
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 - Device ID:
00616784698120
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810180846691
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
00616784698137
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00616784698120
Item #3 - 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