FDA.reportPublic FDA data

ORBIT GALAXY XTRASOFT

Primary DI
10886704030645
Brand
ORBIT GALAXY XTRASOFT
Company
Medos International Sàrl
Model
640CX0410
Catalog number
640CX0410
Device description
ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 10cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II
Published
2015-09-20
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
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
K093973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093973000TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMCodman & Shurtleff, Inc.2010-05-26HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704030645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670403064510886704030645

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

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
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488178Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28