FDA.reportPublic FDA data

SOL-CARE™ Insulin Safety Syringe with Fixed Needle

Primary DI
10818392015710
Brand
SOL-CARE™ Insulin Safety Syringe with Fixed Needle
Company
SOL-MILLENNIUM MEDICAL INC
Model
100089IM
Device description
Used to inject insulin into 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092413000INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESInviro Medical Devices, Inc.2009-09-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818392015710PackageGS1100In Commercial Distribution
20818392015717PackageGS110In Commercial Distribution
00818392015713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201571010818392015710
2081839201571720818392015717
00818392015713008183920157138183920157130818392015713

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Needle Gauge30Gauge
Total Volume0.5Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(404)973-2200SOLMCHUinform@sol-m.com
833-637-0857info@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
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
20818392010446SOL-CARE™ Safety NeedleSN27122016-09-16

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Primary DI, Brand, Company table
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