OptiCross™ HD H74939352050
GUDID 00191506035419
Coronary Imaging Catheters
BOSTON SCIENTIFIC CORPORATION
Intravascular ultrasound imaging catheter, single-use| Primary Device ID | 00191506035419 |
| NIH Device Record Key | a1c2ff19-a5df-4ec4-a730-16e6b7726a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiCross™ HD |
| Version Model Number | H74939352050 |
| Catalog Number | H74939352050 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| 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 |
Device Dimensions
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
| Shaft Length | 135 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 1 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506035419 [Primary] |
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
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 | 2023-09-28 |
| Device Publish Date | 2023-09-20 |
On-Brand Devices [OptiCross™ HD]
| 08714729960768 | Coronary Imaging Catheter |
| 08714729960737 | Coronary Imaging Catheter |
| 00191506035419 | Coronary Imaging Catheters |
Trademark Results [OptiCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTICROSS 85718478 4619353 Live/Registered |
Boston Scientific Scimed, Inc. 2012-08-31 |
 OPTICROSS 79110412 not registered Dead/Abandoned |
Hitachi High-Technologies Corporation 2012-02-01 |
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