FDA.reportPublic FDA data

SOL-M™ Hypodermic Needle

Primary DI
00818392010657
Brand
SOL-M™ Hypodermic Needle
Company
Sol-Millennium Medical, Inc.
Model
112638
Device description
"Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin. 26g x 3/8"" IDB Needle"
Published
2016-09-16
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
10818392010654PackageGS1100In Commercial Distribution
20818392010651PackageGS110In Commercial Distribution
00818392010657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201065410818392010654
2081839201065120818392010651
00818392010657008183920106578183920106570818392010657

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Needle Gauge26Gauge

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
00840368514357TYPENEXMS2203MS22032024-01-04
00840368516535TYPENEXMS2003MS20032024-04-15
00840368516917TYPENEXMS2012PMS2012P2024-05-10
00840368514326TYPENEXMS0103MS01032024-01-04
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
00818392010664SOL-M™ Hypodermic Needle1126122016-09-16
00818392010671SOL-M™ Hypodermic Needle1126582017-10-23
00818392010701SOL-M™ Hypodermic Needle1118102017-10-23
00818392011074SOL-CARE™ Insulin Safety Syringe with Fixed Needle100020IM2016-09-16
00818392012378SOL-M™ Hypodermic Needle11221252016-09-16
00818392012385SOL-M™ Hypodermic Needle1127342016-09-16

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