Diamondback Peripheral 7-10057-01

GUDID 10850000491172

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT

Cardiovascular Systems, Inc.

Mechanical atherectomy system catheter, peripheral

Primary Device ID	10850000491172
NIH Device Record Key	b9b9da3a-d9a4-4d34-b055-0369ecf23edf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Diamondback Peripheral
Version Model Number	DBP-125MICRO145
Catalog Number	7-10057-01
Company DUNS	024954518
Company Name	Cardiovascular Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com
Phone	877-274-0360
Email	customerservice@csi360.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10850000491172 [Primary]

FDA Product Code

MCW	Catheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

[10850000491172]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-11-21
Device Publish Date	2019-11-13

On-Brand Devices [Diamondback Peripheral]

10850000491257	DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
10850000491240	DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
10850000491233	Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
10850000491226	Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
10850000491219	Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
10850000491202	DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
10850000491196	DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
10850000491189	DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
10850000491172	DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
10852528005855	Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 75 cm shaft
10852528005374	Diamondback Peripheral, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
10852528005367	Diamondback Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
10852528005350	Diamondback Peripheral, Radial Access OAD, 1.25mm, 10mm, 200cm shaft
10852528005282	DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
10852528005268	DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
10852528005251	DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
10852528005244	DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
10852528005237	DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
10852528005213	DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
10852528005206	DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
10852528005992	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
10852528005985	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
10852528005978	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid 75 cm shaft
10852528005961	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 75 cm shaft
10852528005954	Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Solid, 145 cm shaft
10852528005947	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 145 cm shaft
10852528005930	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 145 cm shaft
10852528005923	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 145 cm shaft
10852528005916	Diamondback Peripheral, Exchangeable Series, 2.00 Classic, 145 cm shaft
10852528005909	Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
10852528005893	Diamondback Peripheral, Exchangeable Series, 1.75 Solid, 180 cm shaft
10852528005886	Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 200 cm shaft
10852528005879	Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 200 cm shaft
10852528005862	Diamondback Peripheral, Exchangeable Series, 1.25 Solid 75 cm shaft
10852528005848	Diamondback Peripheral, Exchangeable Series, 2.00 Solid, 145 cm shaft
10852528005831	Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 145 cm shaft
10852528005824	Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 145 cm shaft
10852528005817	Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 145 cm shaft
10852528005275	DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
10852528005190	DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
10852528005008	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft
10850000491035	Diamondback Peripheral, Exchangeable Series, Handle Only
10850000491028	Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft
10850000491011	Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft