DEVICE: SOL-GUARD™ TB Safety Syringe with Fixed Needle (10818392014386)
Device Identifier (DI) Information
SOL-GUARD™ TB Safety Syringe with Fixed Needle
200069SG
In Commercial Distribution
Sol-Millennium Medical, Inc.
200069SG
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
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.
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Active | false |
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.
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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 |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 1 Milliliter |
Needle Gauge: 26 Gauge |
Length: 10 Millimeter |
Device Record Status
19e03575-f412-4823-8c3b-e08c926dbe46
October 24, 2024
4
September 16, 2016
October 24, 2024
4
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 |
---|---|---|---|---|---|
20818392014383 | 40 | 10818392014386 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00818392014389
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(404)973-2200
SOLMCHUinform@sol-m.com
SOLMCHUinform@sol-m.com