Progreat Lambda CCM1913AN
GUDID 04987350737281
Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
Vascular microcatheter| Primary Device ID | 04987350737281 |
| NIH Device Record Key | c57c47ee-fe20-4b4e-8464-796f990a283f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Progreat Lambda |
| Version Model Number | CC-MC913AN |
| Catalog Number | CCM1913AN |
| Company DUNS | 691034748 |
| Company Name | TERUMO CLINICAL SUPPLY CO., LTD. |
| 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 | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com |
Device Dimensions
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Catheter Working Length | 130 Centimeter |
| Outer Diameter | 0.64 Millimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 * Fragile. Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987350737281 [Primary] |
| GS1 | 54987350737286 [Package] Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211078
FDA Product Code
| DQO | Catheter, Intravascular, 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 | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
On-Brand Devices [Progreat Lambda]
| 54987350741023 | Micro Catheter System |
| 54987350741009 | Micro Catheter System |
| 04987350740984 | Micro Catheter System |
| 54987350737361 | Micro Catheter System |
| 54987350737347 | Micro Catheter System |
| 54987350737323 | Micro Catheter System |
| 54987350737309 | Micro Catheter System |
| 04987350737281 | Micro Catheter System |
| 54987350737262 | Micro Catheter System |
Trademark Results [Progreat Lambda]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGREAT LAMBDA 88464196 not registered Live/Pending |
Terumo Kabushiki Kaisha 2019-06-07 |
 PROGREAT LAMBDA 88464154 not registered Live/Pending |
Terumo Kabushiki Kaisha 2019-06-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.