FDA.reportPublic FDA data

NA

Primary DI
00878528000037
Brand
NA
Company
Cerenovus, Inc.
Model
CCB000157-00
Catalog number
CCB00015700
Device description
Connecting Cable 157cm Contents: 1 Connecting Cable
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K142429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142429000CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector CableCodman & Shurtleff, Inc.2014-12-24HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878528000037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878528000037008785280000378785280000370878528000037

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, electronic, single-useA noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
607846297
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704074892ENVOY778-258-00B77825800B2026-09-19
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26
10886704086611CEREGLIDENIC42115U2025-09-26
10886704088073CEREGLIDENIC42152UNIC42152U2025-09-26
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704085355CEREGLIDENIC71115UNIC71115U2023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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