DEVICE: SOL-GUARD™ TB Safety Syringe with Fixed Needle (00818392011869)
Device Identifier (DI) Information
SOL-GUARD™ TB Safety Syringe with Fixed Needle
200067SG
In Commercial Distribution
Sol-Millennium Medical, Inc.
200067SG
In Commercial Distribution
Sol-Millennium Medical, Inc.
The SOL-GUARD™ Safety Syringe is intended for the delivery of vaccines. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick. 1.0ml Safety Syringe with 28g x 1/2" needle
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47017 | General-purpose syringe, single-use |
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.
|
Active | false |
| 17812 | Needle guard |
A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. 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 | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Needle Gauge: 28 Gauge |
| Length: 12.5 Millimeter |
| Total Volume: 1 Milliliter |
Device Record Status
c50329af-8c74-44d0-8646-179c8b62a095
May 02, 2025
5
September 16, 2016
May 02, 2025
5
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20818392011863 | 8 | 10818392011866 | In Commercial Distribution | Case | |
| 10818392011866 | 100 | 00818392011869 | In Commercial Distribution | Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8336370857
info@solm.com
info@solm.com