FDA.reportPublic FDA data

CODMAN

Primary DI
10886704001997
Brand
CODMAN
Company
Cerenovus, Inc.
Model
20-1747
Catalog number
201747
Device description
CODMAN SLIM-LINE Aneurysm Clip Reinforcing Angle 30 Degrees 6mm x 18mm
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCHCLIP, ANEURYSM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091921000CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.2009-09-08HCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704001997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400199710886704001997

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysm clipA metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603703679LAZICPeter Lazic GmbHHCH2025-10-30
04250603703778LAZICPeter Lazic GmbHHCH2025-10-30
04250603703860LAZICPeter Lazic GmbHHCH2025-10-30
04250603709527LAZICPeter Lazic GmbHHCH2025-08-07
04250603714835LAZICPeter Lazic GmbHHCH2025-08-07
04250603733911LAZICPeter Lazic GmbHHCH2025-08-07
04250603753018LAZICPeter Lazic GmbHHCH2025-06-30
04250603727194LAZICPeter Lazic GmbHHCH2025-06-16
04250603734031LAZICPeter Lazic GmbHHCH2025-06-16
04250603733980LAZICPeter Lazic GmbHHCH2025-05-13
04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
G586N697205A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N697206A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N6971710NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6971730NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6972700NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
04250603707424LAZICPeter Lazic GmbHHCH2024-09-12
04250603726791LAZICPeter Lazic GmbHHCH2024-03-25
04250603727057LAZICPeter Lazic GmbHHCH2024-03-25
00842331190506Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190513Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190520Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
04946329389340Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389357Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389364Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389371Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19