Circulo 15R2011-06-001

GUDID 10816349012683

Lake Region Medical

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	10816349012683
NIH Device Record Key	a00aab22-afe7-4c82-abfd-ef104267c103
Commercial Distribution Status	In Commercial Distribution
Brand Name	Circulo
Version Model Number	DAIBW-003
Catalog Number	15R2011-06-001
Company DUNS	031108704
Company Name	Lake Region Medical
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	true
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

Device Dimensions

Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch
Length	275 Centimeter
Outer Diameter	35 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816349012686 [Primary]
GS1	10816349012683 [Package] Contains: 00816349012686 Package: [5 Units] In Commercial Distribution

FDA Product Code

DQX	Wire, Guide, Catheter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-10-21
Device Publish Date	2022-10-13

On-Brand Devices [Circulo]

10816349012683	DAIBW-003
00816349012662	DAIBW-001

Trademark Results [Circulo]

Mark Image Registration \| Serial	Company Trademark Application Date
CIRCULO 97342512 not registered Live/Pending	St. Jude Medical, Cardiology Division, Inc. 2022-04-01
CIRCULO 97312417 not registered Live/Pending	Circulo, Inc. 2022-03-15
CIRCULO 74016668 not registered Dead/Abandoned	Industria De Linhas Leopoldo Schmalz S.A. 1990-01-05
CIRCULO 73385243 1258585 Dead/Cancelled	Industria de Linhas Leopoldo Schmalz S.A. 1982-09-13