AccessGUDID - DEVICE: SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle (00818392011715)

GUDID

Device Identifier (DI) Information

Brand Name: SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle
Version or Model: 190072IM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sol-Millennium Medical, Inc.

Primary DI Number: 00818392011715
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069590113 *Terms of Use

Device Description: Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45042	Metered-delivery hypodermic syringe/needle	A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEG	SYRINGE, ANTISTICK

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Needle Gauge: 21 Gauge
Length: 40 Millimeter

Device Record Status

Public Device Record Key: f1ad5137-3a6c-4038-8296-ff2726c3ab4a
Public Version Date: October 24, 2024
Public Version Number: 3
DI Record Publish Date: September 16, 2016