FDA.reportPublic FDA data

Medusa Multi-Coil

Primary DI
10857798005017
Brand
Medusa Multi-Coil
Company
ENDOSHAPE, INC.
Model
MMC-122
Catalog number
002156
Published
2015-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10857798005017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085779800501710857798005017

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-870-5070customerservice@endoshape.com

Regulatory Flags#

DUNS number
788545692
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857798005000Medusa Multi-CoilMMC-1200021552015-09-23
10857798005024Medusa Multi-CoilMMC074-450026482015-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488710Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28