Model: SYPR-03GA-WP
Catalog: SYPR-03GA-WP6; SYPR-03GA-WP60
DI: 00383790012478
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
0.3mL Precision Syringe
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8eb9817e-425e-421f-8e99-7680728a0f44
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:
Yes
Identifiers
Item #1 - Device ID:
00383790012478
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
box
Item #2 - Device ID:
10383790012475
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
6
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00383790012478
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
box
Item #3 - Device ID:
10383790012482
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
60
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00383790012478
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Pkg Type:
box
Item #4 - Device ID:
20383790012472
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
21
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
10383790012475
Item #4 - Device ID Issuing Agency:
GS1
Item #5 - Pkg Type:
case
Item #5 - Device ID:
40383790012476
Item #5 - Pkg Status:
In Commercial Distribution
Item #5 - Pkg Quantity:
18
Item #5 - Device ID Type:
Package
Item #5 - Contains DINumber:
20383790012472
Item #5 - Device ID Issuing Agency:
GS1
Item #6 - Pkg Type:
case
Item #6 - Device ID:
40383790012483
Item #6 - Pkg Status:
In Commercial Distribution
Item #6 - Pkg Quantity:
48
Item #6 - Device ID Type:
Package
Item #6 - Contains DINumber:
10383790012482
Item #6 - Device ID Issuing Agency:
GS1
GMDN
Code: 47017
Name: General-purpose syringe, single-use
Definition:
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
FDA Product Codes
FMF
Syringe, Piston
Premarket Submissions
Submission Number:
K191359
Supplement Number:
000