FDA.reportPublic FDA data

CASHMERE CERECYTE

Primary DI
00878528004530
Brand
CASHMERE CERECYTE
Company
Medos International Sàrl
Model
CRC140609-30
Catalog number
CRC14060930
Device description
CASHMERE microcoil CASHMERE 14 CERECYTE Coil 6mm x 9cm 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
00878528004530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878528004530008785280045308785280045300878528004530

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
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

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Primary DI, Brand, Company table
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07613327578713Target TetraStryker CorporationHCG2022-12-19
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07613327580105Target TetraStryker CorporationHCG2022-12-19
07613327466379TARGETStryker CorporationHCG2019-09-05
07613327466393TARGETStryker CorporationHCG2019-09-05
07613327466409TARGETStryker CorporationHCG2019-09-05
07613327128307TARGETStryker CorporationHCG2017-06-26
07613327128345TARGETStryker CorporationHCG2017-06-26
07613327128383TARGETStryker CorporationHCG2017-06-26
M4244002C03050Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03120Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03150Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03200Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04080Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04120Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04150Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04200Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04300Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04350Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30