FDA.reportPublic FDA data

NA

Primary DI
10888551044950
Brand
NA
Company
STERILMED, INC.
Model
STJG408324
Catalog number
STJG408324
Device description
Agilis™ NxT Steerable Introducer: Bi-Directional, Large Curl 50.0 mm, 71 cm, 8.5F ID; Dilator: 94 cm
Published
2016-09-22
Public version status
Update
Distribution status
Not 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
PNEReprocessed catheter introducer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNEReprocessed Catheter IntroducerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152090000Reprocessed Steerable IntroducerSterilmed, Inc.2016-03-23PNE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551044950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855104495010888551044950

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898131547N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898131554N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898131561N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898130144N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130151N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130168N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130175N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130182N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130199N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130205N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130212N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898120244N/AINNOVATIVE HEALTH LLCPNE2019-03-06
10841898128172N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898128196N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898120251N/AINNOVATIVE HEALTH LLCPNE2018-05-01
10841898120268N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120275N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120282N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10888551044912NASTERILMED, INC.PNE2016-09-22
10888551044929NASTERILMED, INC.PNE2016-09-22