FDA.reportPublic FDA data

SafeSept Blunt Needle

Primary DI
30858769006396
Brand
SafeSept Blunt Needle
Company
PPMDM
Model
SBN189
Catalog number
SBN189
Device description
89cm Transseptal Extended Cannula Curve 1
Published
2021-03-15
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

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210328000SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC2021-03-05DRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30858769006396PackageGS15In Commercial Distribution
00858769006395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085876900639630858769006396
00858769006395008587690063958587690063950858769006395

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal needle, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081047841
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
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
00858769006487SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006500SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006524SafeSept RF Transseptal GuidewireSSRF1352026-03-23
00858769006531SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
00858769006548SafeSept RF Transseptal GuidewireSSRF2352026-03-23
00858769006555SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
30858769006488SafeSept RF Transseptal GuidewireSSRF132SSRF1322026-03-23
00858769006494SafeSept RF Transseptal GuidewireSSRF132RSSRF132R2026-03-23
30858769006501SafeSept RF Transseptal GuidewireSSRF2322026-03-23
00858769006517SafeSept RF Transseptal GuidewireSSRF232R2026-03-23
30858769006525SafeSept RF Transseptal GuidewireSSRF1352026-03-23
30858769006532SafeSept RF Transseptal GuidewireSSRF135RSSRF135R2026-03-23
30858769006549SafeSept RF Transseptal GuidewireSSRF2352026-03-23
30858769006556SafeSept RF Transseptal GuidewireSSRF235R2026-03-23
00858769006425SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
00858769006449SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02
00858769006456SafeSharp Transseptal NeedleCLICK171CLICK1712024-07-02
00858769006470SafeSharp Transseptal NeedleCLICK198CLICK1982024-07-02
30858769006426SafeSharp Transseptal NeedleCLICK071CLICK0712024-07-02
30858769006440SafeSharp Transseptal NeedleCLICK098CLICK0982024-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135391Redemption VILEX LLCDRC2026-01-12
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28
00858769006241Transseptal NeedlePPMDMDRC2018-11-28
00858769006258Transseptal NeedlePPMDMDRC2018-11-28
10884450151850Merit Advance®Merit Medical Systems, Inc.DRC2018-06-11
00858769006104SafeSept Transseptal GuidwirePPMDMDRC2018-03-02