FDA.reportPublic FDA data

N/A

Primary DI
10841898129766
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
407201
Device description
Reprocessed BRK-1 Transseptal Needle, 71 cm
Published
2020-08-26
Public version status
New
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
NMKTrocar, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NMKTrocar, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192998000Reprocessed BRK Transseptal NeedleInnovative Health, LLC2020-07-22NMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898129766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189812976610841898129766

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal needle, reprocessedA device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-400-3740regulatory@innovative-health.com

Regulatory Flags#

DUNS number
015575953
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841898137273N/AN/A116574842026-06-01
10841898137280N/AN/A116574852026-06-01
10841898137174N/AN/A115108262026-05-07
10841898137266N/AN/A115108252026-05-07
10841898137297N/AN/AVXW-35-230-J2026-05-07
10841898137303N/AN/AVXW-35-180-J2026-05-07
10841898137310N/AN/AVXW-35-230-P2026-05-07
10841898137327N/AN/AVXW-35-180-P2026-05-07
10841898137587N/AN/AVXW-CFD-180J2026-05-07
10841898137594N/AN/AVXW-CFD-180P2026-05-07
10841898137600N/AN/AVXW-CFD-230P2026-05-07
10841898137617N/AN/AVXW-CWM-180J2026-05-07
10841898137624N/AN/AVXW-CWM-180P2026-05-07
10841898137631N/AN/AVXW-CWM-230P2026-05-07
10841898137242N/AN/AD1337032026-04-17
10841898123214N/AN/A104392362018-11-12
10841898123221N/AN/A104390722018-11-12
10841898123238N/AN/A104390112018-11-12
10841898123245N/AN/A104385772018-11-12
10841898110108N/AN/A101359362016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898129759N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129773N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129780N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129797N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129803N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129810N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129827N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129834N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129841N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129858N/AINNOVATIVE HEALTH LLCNMK2020-08-26
10841898129865N/AINNOVATIVE HEALTH LLCNMK2020-08-26
04953170071591MOUTHPIECEOLYMPUS MEDICAL SYSTEMS CORP.NMK2016-09-21