FDA.reportPublic FDA data

SOL-M™ Hypodermic Needle

Primary DI
00818392010701
Brand
SOL-M™ Hypodermic Needle
Company
Sol-Millennium Medical, Inc.
Model
111810
Device description
SOL-M Hypodermic Needle 18G*1
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112777000SOL-M EXCHANGEABLE NEEDLESSol-Milennium Medical, Inc.2012-02-24FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818392010708PackageGS1100In Commercial Distribution
20818392010705PackageGS110In Commercial Distribution
00818392010701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201070810818392010708
2081839201070520818392010705
00818392010701008183920107018183920107010818392010701

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Needle Gauge18Gauge

Contacts#

Phone, Email table
PhoneEmail
833-637-0857info@solm.com

Regulatory Flags#

DUNS number
069590113
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810018097462SOL-M Slip Tip Syringe 5 ml without needleP180005ST2025-03-30
00810018097493SOL-M 3ml Slip Tip Syringe w/o NeedleP180003ST2025-03-30
00810018097523SOL-M 1ml Slip Tip Syringe w/o NeedleP1800112025-03-30
00810018097646SOL-M Slip Tip Syringe 10 ml without needleP180010ST2025-03-30
00810018098551SOL-M 10ml Eccentric Tip Syringe w/o NeedleP180010ET2025-04-03
00810018098636SOL-M 20ml Slip Tip Syringe w/o NeedleP180020ST2025-03-30
00810018098698SOL-M 60ml Eccentric Tip Syringe w/o NeedleP180060ET2025-04-22
00810018098957SOL-M 1ml Slip Tip Syringe Sterile Convenience TrayP180011T2025-03-30
00810062435333SOL-M 30ml Slip Tip Syringe w/o Needle P180030ST2025-04-21
00810062435340SOL-M 60ml Slip Tip Syringe w/o NeedleP180060ST2025-04-21
00818392010657SOL-M™ Hypodermic Needle1126382016-09-16
00818392010664SOL-M™ Hypodermic Needle1126122016-09-16
00818392010671SOL-M™ Hypodermic Needle1126582017-10-23
00818392011074SOL-CARE™ Insulin Safety Syringe with Fixed Needle100020IM2016-09-16
00818392012378SOL-M™ Hypodermic Needle11221252016-09-16
00818392012385SOL-M™ Hypodermic Needle1127342016-09-16
00818392012743SOL-M™ Hypodermic Needle1119152016-09-16
00818392012750SOL-M™ Hypodermic Needle1131122017-10-23
00818392012828SOL-M™ Hypodermic Needle1124102016-09-16
00818392013924SOL-CARE™ Insulin Syringe w/Fixed Needle100091IM2017-10-23

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Primary DI, Brand, Company table
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08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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