FDA.reportPublic FDA data

RUBY Coil

Primary DI
00814548018560
Brand
RUBY Coil
Company
PENUMBRA, INC.
Model
RBY2C0320-B
Catalog number
RBY2C0320
Device description
Ruby Standard, 3x20
Published
2018-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548018560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548018560008145480185608145480185600814548018560

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Regulatory Flags#

DUNS number
191077671
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M4244002C03060Penumbra Coil 4004002C03062016-07-30
M4244002C03100Penumbra Coil 4004002C03102016-07-30
M4244002C04080Penumbra Coil 4004002C04082016-07-30
M4244002C04120Penumbra Coil 4004002C04122016-07-30
M4244002C05060Penumbra Coil 4004002C05062016-07-30
M4244002C05100Penumbra Coil 4004002C05102016-07-30
M4244002C06100Penumbra Coil 4004002C06102016-07-30
M4244002C06150Penumbra Coil 4004002C06152016-07-30
M4244002C07100Penumbra Coil 4004002C07102016-07-30
M4244002C07150Penumbra Coil 4004002C07152016-07-30
M4244002C07200Penumbra Coil 4004002C07202016-07-30
M4244002C08150Penumbra Coil 4004002C08152016-07-30
M4244002C08200Penumbra Coil 4004002C08202016-07-30
M4244002C08300Penumbra Coil 4004002C08302016-07-30
M4244002C09150Penumbra Coil 4004002C09152016-07-30
M4244002C09250Penumbra Coil 4004002C09252016-07-30
M4244002C09350Penumbra Coil 4004002C09352016-07-30
M4244002C10200Penumbra Coil 4004002C10202016-07-30
M4244002C10300Penumbra Coil 4004002C10302016-07-30
M4244002C10400Penumbra Coil 4004002C10402016-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28