Circulo 15R2011-06-001
GUDID 10816349012683
Lake Region Medical
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 |
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