FDA.reportPublic FDA data

RUBY Coil

Primary DI
M424RBY2C16600
Brand
RUBY Coil
Company
PENUMBRA, INC.
Model
RBY2C1660-A
Device description
PC400 Cplx Std, 16x60
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103305000PENUMBRA EMBOLIZATION COIL SYSTEMPenumbra, Inc.2011-01-26HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M424RBY2C16600PrimaryHIBCC0
00814548013053SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548013053008145480130538145480130530814548013053

GMDN Terms#

Term, Definition table
TermDefinition
Embolization implant kitA collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815948025134BenchmarkBMK6F95M-A2023-01-05
00815948025141BenchmarkBMK6F105-A2023-01-05
00815948025158BenchmarkBMK6F105M-A2023-01-05
00815948025165BenchmarkBMK6F115-A2023-01-05
00815948025172BenchmarkBMK6F115M-A2023-01-05
00815948025189BenchmarkBMK6F95BER120-A2023-01-05
00815948025196BenchmarkBMK6F95SIM120-A2023-01-05
00815948025202BenchmarkBMK6F95MBER120-A2023-01-05
00815948025219BenchmarkBMK6F95MSIM120-A2023-01-05
00815948025226BenchmarkBMK6F105BER130-A2023-01-05
00815948025233BenchmarkBMK6F105SIM130-A2023-01-05
00815948025240BenchmarkBMK6F105MBER130-A2023-01-05
00815948025257BenchmarkBMK6F105MSIM130-A2023-01-05
00815948022553Indigo SystemLITNG12HTORQ100-A2020-07-15
00815948022560Indigo SystemLITNG12XTORQ100-A2020-07-15
00815948022577Indigo SystemLITNG12HTORQ115-A2020-07-15
00815948022591Indigo SystemLITNG12XTORQ115-A2020-07-15
00815948022904Indigo SystemLITNG12HTORQ1002020-07-15
00815948022911Indigo SystemLITNG12XTORQ1002020-07-15
00815948022928Indigo SystemLITNG12HTORQ1152020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488178Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488710Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488741Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488758Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488765Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28