Aligned Medical Solutions

Primary DI
00850064198676
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
MISX-6F07
Catalog number
MISX-6F07
Device description
Introducer Set
Published
2026-07-17
Public version status
New
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261529000Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC2026-07-06DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850064198673PackageGS1100In Commercial Distribution
00850064198676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006419867310850064198673
00850064198676008500641986768500641986760850064198676

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1 800-637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064198683Aligned Medical SolutionsMISX-7F07MISX-7F072026-07-17
B098AMS11096B0Aligned Medical SolutionsAMS11096BAMS11096B2026-07-19
B098AMS188250Aligned Medical SolutionsAMS18825AMS188252026-07-19
B098AMS192180Aligned Medical SolutionsAMS19218AMS192182026-07-19
B098AMS192900Aligned Medical SolutionsAMS19290AMS192902026-07-19
B098AMS12381C0Aligned Medical SolutionsAMS12381CAMS12381C2026-07-12
B098AMS14885C0Aligned Medical SolutionsAMS14885CAMS14885C2026-07-12
B098AMS17983A0Aligned Medical SolutionsAMS17983AAMS17983A2026-07-12
B098AMS18306A0Aligned Medical SolutionsAMS18306AAMS18306A2026-07-12
B098AMS184440Aligned Medical SolutionsAMS18444AMS184442026-07-12
B098AMS190580Aligned Medical SolutionsAMS19058AMS190582026-07-12
B098AMS192890Aligned Medical SolutionsAMS19289AMS192892026-07-12
B098AMS192920Aligned Medical SolutionsAMS19292AMS192922026-07-12
B098AMS193400Aligned Medical SolutionsAMS19340AMS193402026-07-12
B098AMS8144C0Aligned Medical SolutionsAMS8144CAMS8144C2026-07-12
B098AMS10930A0Aligned Medical SolutionsAMS10930AAMS10930A2026-07-03
B098AMS16803A0Aligned Medical SolutionsAMS16803AAMS16803A2026-07-03
B098AMS180170Aligned Medical SolutionsAMS18017AMS180172026-07-03
B098AMS193380Aligned Medical SolutionsAMS19338AMS193382026-07-05
B098AMS1217B0Aligned Medical SolutionsAMS1217BAMS1217B2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
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