FDA.reportPublic FDA data

DELTAMAXX CERECYTE

Primary DI
10878528008573
Brand
DELTAMAXX CERECYTE
Company
Medos International Sàrl
Model
CDX180625-30
Catalog number
CDX18062530
Device description
DELTAMAXX microcoil DELTAMAXX 18 CERECYTE Coil 6mm x 25cm 190cm Contents: 1 Detachable Coil System Coil Type: DELTAMAXX 18 CERECYTE Coil
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
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
K120274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120274000DELTAMAXX 18 MICROCOIL SYSTEMCodman and Shurtleff, Inc.2012-03-02HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10878528008573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1087852800857310878528008573

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA 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
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

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
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

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