FDA.reportPublic FDA data

POD

Primary DI
00814548017679
Brand
POD
Company
PENUMBRA, INC.
Model
RBYPODJ60-A
Device description
RBYPODJ60
Published
2017-10-27
Public version status
Update
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
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170852000POD Packing CoilPenumbra, Inc.2017-07-19HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548017679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548017679008145480176798145480176790814548017679

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169720042ELEMENT Vascular Access SystemELMNT17F13-A2024-12-16
00810169720059ELEMENT Vascular Access SystemELMNT17F33-A2024-12-16
00810169720066ELEMENT Vascular Access SystemELMNT17F45-A2024-12-16
00810169720073ELEMENT Vascular Access SystemELMNT17F65-A2024-12-16
00810169720080ELEMENT Vascular Access SystemELMNT17F70-A2024-12-16
00810169720097ELEMENT Vascular Access SystemELMNT17F80-A2024-12-16
00815948028029MIDWAY43MWAY115-A2024-04-02
00815948028036MIDWAY62MWAY125-A2024-04-02
00815948028180MIDWAY43MWAY125-A2024-04-02
00815948028197MIDWAY62MWAY115-A2024-04-02
00815948026216Benchmark MAX SystemBMX96100SIM125-B2023-06-27
00815948026223Benchmark MAX SystemBMX96100MSIM125-B2023-06-27
00815948026230Benchmark MAX SystemBMX96100H1125-B2023-06-27
00815948026247Benchmark MAX SystemBMX96100MH1125-B2023-06-27
00815948026254Benchmark MAX SystemBMX96100BER125-B2023-06-27
00815948026261Benchmark MAX SystemBMX96100MBER125-B2023-06-27
00815948026278Benchmark MAX SystemBMX96100SIMV125-B2023-06-27
00815948026285Benchmark MAX SystemBMX96100MSIMV125-B2023-06-27
00815948026292Benchmark MAX SystemBMX96100-B2023-06-27
00815948026308Benchmark MAX SystemBMX9690SIM125-B2023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540688897GDC-10Stryker CorporationHCG2015-09-21
04546540688910GDC-10Stryker CorporationHCG2015-09-21
04546540688934GDC-10Stryker CorporationHCG2015-09-21
04546540688958GDC-10Stryker CorporationHCG2015-09-21
04546540689054GDC-10Stryker CorporationHCG2015-09-21
04546540689061GDC-10Stryker CorporationHCG2015-09-21
04546540689078GDC-10Stryker CorporationHCG2015-09-21
04546540689085GDC-10Stryker CorporationHCG2015-09-21
04546540689092GDC-10Stryker CorporationHCG2015-09-21
04546540689108GDC-10Stryker CorporationHCG2015-09-21
04546540689115GDC-10Stryker CorporationHCG2015-09-21
04546540689122GDC-10Stryker CorporationHCG2015-09-21
04546540689139GDC-10Stryker CorporationHCG2015-09-21
04546540689146GDC-10Stryker CorporationHCG2015-09-21
04546540689153GDC-10Stryker CorporationHCG2015-09-21
04546540689160GDC-10Stryker CorporationHCG2015-09-21
04546540689177GDC-10Stryker CorporationHCG2015-09-21
04546540689184GDC-10Stryker CorporationHCG2015-09-21
04546540689191GDC-10Stryker CorporationHCG2015-09-21
04546540689207GDC-10Stryker CorporationHCG2015-09-21
04546540689214GDC-10Stryker CorporationHCG2015-09-21
04546540689221GDC-10Stryker CorporationHCG2015-09-21
04546540689238GDC-10Stryker CorporationHCG2015-09-21
04546540689245GDC-10Stryker CorporationHCG2015-09-21
04546540689252GDC-10Stryker CorporationHCG2015-09-21
04546540689269GDC-10Stryker CorporationHCG2015-09-21
04546540689276GDC-10Stryker CorporationHCG2015-09-21
04546540689283GDC-10Stryker CorporationHCG2015-09-21
04546540689290GDC-10Stryker CorporationHCG2015-09-21
04546540689306GDC-10Stryker CorporationHCG2015-09-21