FDA.reportPublic FDA data

CASHMERE CERECYTE

Primary DI
00878528004417
Brand
CASHMERE CERECYTE
Company
Medos International Sàrl
Model
CRC140303-30
Catalog number
CRC14030330
Device description
CASHMERE microcoil CASHMERE 14 CERECYTE Coil 3mm x 3cm 190cm Contents: 1 Detachable Coil System
Published
2015-09-20
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
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072173000MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRCMicrus Endovascular Corporation2007-10-05HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878528004417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878528004417008785280044178785280044170878528004417

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA sterile, non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; 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 Temperature0 Degrees Celsius45 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit110 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647845TRIALTIS5161-00-508051610050802026-07-04
10705034647852TRIALTIS5161-00-508351610050832026-07-04
10705034647883TRIALTIS5161-00-508151610050812026-07-04
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488727Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488796Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488826Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488864Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488932Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488994Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489052Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489076Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28