FDA.reportPublic FDA data

NA

Primary DI
00836462011045
Brand
NA
Company
Micro Therapeutics, Inc.
Model
ID-1-5
Catalog number
ID-1-5
Device description
Instant Detacher
Published
2015-10-22
Public version status
Update
Distribution status
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
K060747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060747000FX DETACHABLE COIL SYSTEMMicro Therapeutics, Inc.2007-04-24HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462011045PrimaryGS10
10884521547063Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462011045008364620110458364620110450836462011045
1088452154706310884521547063

GMDN Terms#

Term, Definition table
TermDefinition
Embolization implant inserterA sterile, long, thin surgical device used to advance an embolization implant, e.g. an embolic coil, through the length of an appropriate catheter so that the implant is ready for discharge (implantation) when the catheter has been surgically positioned at the target site in an artery or vein. The inserter, also known as a pusher, is removed prior to the discharge of the implant. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
826110710
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536041950PhenomTM Plus CatheterFG19135-1030-1S2019-04-22
00847536005648HyperGlideTM104-45202016-04-03
00199150045532OnyxTM Liquid Embolic System (LES)105-7100-0602026-06-07
00763000488017Axium™ Detachable Coil SystemQC-2.5-4-HELIX2022-10-28
00763000488192Axium™ Detachable Coil SystemQC-10-20-HELIX2022-10-28
00763000488239Axium™ Detachable Coil SystemQC-14-30-HELIX2022-10-28
00763000488260Axium™ Detachable Coil SystemQC-16-40-HELIX2022-10-28
00763000488727Axium™ Detachable Coil SystemQC-25-50-3D2022-10-28
00763000488796Axium™ Detachable Coil SystemNC-3-4-HELIX2022-10-28
00763000488826Axium™ Detachable Coil SystemNC-4-8-HELIX2022-10-28
00763000488864Axium™ Detachable Coil SystemPC-2-3-HELIX2022-10-28
00763000488932Axium™ Detachable Coil SystemPC-4-8-HELIX2022-10-28
00763000488994Axium™ Detachable Coil SystemPC-7-20-HELIX2022-10-28
00763000489052Axium™ Detachable Coil SystemPC-10-20-HELIX2022-10-28
00763000489076Axium™ Detachable Coil SystemPC-2-2-3D2022-10-28
00763000489137Axium™ Detachable Coil SystemPC-4-6-3D2022-10-28
00847536032866AxiumTMNC-2-6-HELIX2019-06-29
00847536033306AxiumTMPC-6-15-3D2019-06-29
00847536033368AxiumTMPC-8-20-3D2019-06-29
00847536029668AxiumTMQC-8-30-HELIX2019-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327635096InZone ISTStryker CorporationHCG2026-07-08
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
M242RBYPODJ150PODPENUMBRA, INC.HCG2024-08-15
M424RBYPODJ150PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ600PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ450PODPENUMBRA, INC.HCG2016-08-01
M4244002C03060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04080Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04120Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C06100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30