FDA.report

SOL-GUARD™ TB Safety Syringe with Fixed Needle

Primary DI
20818392014284
Brand
SOL-GUARD™ TB Safety Syringe with Fixed Needle
Company
SOL-MILLENNIUM MEDICAL INC
Model
200090SG
Device description
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.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MEGSYRINGE, ANTISTICK

Product Code Classifications

CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818392014287PackageGS1100In Commercial Distribution
20818392014284PackageGS18In Commercial Distribution
00818392014280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201428710818392014287
2081839201428420818392014284
00818392014280008183920142808183920142800818392014280

GMDN Terms

TermDefinition
General-purpose syringe, single-useA 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.

Device Sizes

TypeValueUnit
Length12.5Millimeter
Needle Gauge27Gauge
Total Volume0.5Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(404)973-2200SOLMCHUinform@sol-m.com
8336370857info@solm.com

Regulatory Flags

DUNS number
069590113
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10818392018537SOL-CARE Safety NeedlePSN22152019-04-10
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10818392018629SOL-CARE Safety NeedlePSN23102019-04-10
20818392018664SOL-CARE Safety NeedlePSN25582019-04-10
20818392018671SOL-CARE Safety NeedlePSN25102019-04-10
10818392018728SOL-CARE Safety NeedlePSN27122019-04-10
10818392010401SOL-CARE™ Safety NeedleSN30122016-09-16
10818392010432SOL-CARE™ Safety NeedleSN27582016-09-16

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