FDA.reportPublic FDA data

SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle

Primary DI
20818392012815
Brand
SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle
Company
SOL-MILLENNIUM MEDICAL INC
Model
100059IM
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.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEGSYRINGE, ANTISTICK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818392012818PackageGS1100In Commercial Distribution
20818392012815PackageGS18In Commercial Distribution
00818392012811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201281810818392012818
2081839201281520818392012815
00818392012811008183920128118183920128110818392012811

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Needle Gauge18Gauge
Total Volume3Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840368517099TYPENEX MS2012PMS2012P2024-05-10
00840368516542TYPENEX MS2003MS20032024-04-15
00840368514326TYPENEX MS0103MS01032024-01-04
00840368514364TYPENEX MS2203MS22032024-01-04
20818392014666SOL-CARE Safety Multi-Sample Needle SMSN211252019-10-16
20818392014680SOL-CARE Safety Multi-Sample Needle SMSN221252019-10-16
20818392014956SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH211252019-10-16
20818392014970SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH221252019-10-16
20818392018596SOL-CARE Safety NeedlePSN21102019-04-12
10818392018612SOL-CARE Safety NeedlePSN22102019-04-12
20818392018749SOL-CARE Safety NeedlePSN30122019-04-12
10818392018452SOL-CARE Safety NeedlePSN18152019-04-10
10818392018537SOL-CARE Safety NeedlePSN22152019-04-10
10818392018568SOL-CARE Safety NeedlePSN25152019-04-10
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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Primary DI, Brand, Company table
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MHC14301060EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14301080EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14305060EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14305080EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
09347144013109Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
00613703101419VanishPoint®RETRACTABLE TECHNOLOGIES, INC.MEG2025-06-08
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10812460024772Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460024789Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026240Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026271Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026295Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
00810008214527ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm)MediVena, LLCMEG2024-02-26
20612479268719McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
20612479268740McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
40612479260823McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
40612479260854McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27