Micro Access

Primary DI
H787065086015
Brand
Micro Access
Company
ANGIODYNAMICS, INC.
Model
06508601
Device description
Echogenic Needle
Published
2016-09-20
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
DQRCANNULA, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQRCannula, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051655000ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.2005-09-12DQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787065086015PackageHIBCC10In Commercial Distribution
H787065086010PrimaryHIBCC0
15051684012157SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401215715051684012157

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 Temperature027 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051684023955Uni-Fuse+H787124018640124018642024-08-01
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
15051684023856Uni-Fuse+H787124018520124018522024-08-01
15051684023863Uni-Fuse+H787124018540124018542024-08-01
15051684023870Uni-Fuse+H787124018550124018552024-08-01
15051684023887Uni-Fuse+H787124018570124018572024-08-01
15051684023894Uni-Fuse+H787124018580124018582024-08-01
15051684023900Uni-Fuse+H787124018590124018592024-08-01
15051684023924Uni-Fuse+H787124018610124018612024-08-01
15051684023931Uni-Fuse+H787124018620124018622024-08-01
15051684023948Uni-Fuse+H787124018630124018632024-08-01
15051684030069NanoKnifeH78720300351US020300351US2026-05-04
15051684013727NanoKnifeH78720300301US020300301US2026-04-30
15051684017930NanoKnifeH787204001090204001092026-04-30
15051684017947NanoKnifeH787204001100204001102026-04-30
15051684017954NanoKnifeH787204003010204003012026-04-30
15051684029643NanoKnifeH787204001110204001112026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479400167enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401034enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401058enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401072enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479400174enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401041enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401065enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
00840479401089enableCV OptiSite™ Arterial Perfusion CannulaENABLECV INC.DQR2026-02-06
05415067042835NAST. JUDE MEDICAL, INC.DQR2022-02-16
H787065068010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068030Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068040Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065068050Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072030Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072040Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065072100MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072110MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072120MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065072130MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065076010EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065076020EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065076030EmbosafeANGIODYNAMICS, INC.DQR2016-09-20
H787065084020MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065084030MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065084040MorpheusANGIODYNAMICS, INC.DQR2016-09-20
H787065086010Micro AccessANGIODYNAMICS, INC.DQR2016-09-20
H787065086020Micro AccessANGIODYNAMICS, INC.DQR2016-09-20