BraidE Embolization Assist Device

Primary DI
07290015107372
Brand
BraidE Embolization Assist Device
Company
RAPID MEDICAL LTD
Model
BRPP7004
Device description
temporary embolization assist device, peripheral
Published
2026-04-14
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

Product Codes#

Code, Name table
CodeName
QZUTemporary Embolization Assist Device, Peripheral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZUTemporary Embolization Assist Device, PeripheralCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230064000BraidE Embolization Assist DeviceRapid Medical , Ltd.2024-02-21QZU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015107372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015107372072900151073727290015107372

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Regulatory Flags#

DUNS number
532702946
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015107303Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107266Tigertriever Revascularization DeviceTRPP7155TRPP71552021-04-05
07290015107273Tigertriever 17 Revascularization DeviceTRPP71662021-04-05
07290015107341Tigertriever 25 Revascularization DeviceTRPP71252026-03-16
07290015107402Tigertriever 17 Ultra Revascularization DeviceTRPP72662025-11-17
07290015107358Drivewire 24 Guidewire DRPP24112025-04-06
17290015107300Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107235Drivewire LRDRLR74642021-08-26
07290015107242Drivewire SRDRSR74632021-08-26
07290015107150Comaneci 17 ANPP71992019-05-17
07290015107136ComaneciANPP71772019-05-17
07290015107143Comaneci Petit ANPP71882019-05-17
27290015107154Comaneci 17 ANPP71992019-05-17