FDA.reportPublic FDA data

SOL-CARE Safety Needle

Primary DI
10818392018612
Brand
SOL-CARE Safety Needle
Company
SOL-MILLENNIUM MEDICAL INC
Model
PSN2210
Device description
SOL-CARE Safety Needle 22Gx1
Published
2019-04-12
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
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818392018612PackageGS1100In Commercial Distribution
20818392018619PackageGS18In Commercial Distribution
00818392018615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201861210818392018612
2081839201861920818392018619
00818392018615008183920186158183920186150818392018615

GMDN Terms#

Term, Definition table
TermDefinition
Needle guardA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Needle Gauge22Gauge

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
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
20818392010453SOL-CARE™ Safety NeedleSN26382016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037125MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037132MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037156MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037262MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037279MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038269MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038283MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31