Progreat Lambda CCM1916AN
GUDID 54987350741009
Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
Vascular microcatheter| Primary Device ID | 54987350741009 |
| NIH Device Record Key | d118481f-089a-4856-a368-22943033af8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Progreat Lambda |
| Version Model Number | CC*M1916AN |
| Catalog Number | CCM1916AN |
| 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
Device Dimensions
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 Millimeter |
| Length | 165 Centimeter |
| Catheter Inner Diameter | 0.48 Millimeter |
| Outer Diameter | 0.64 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987350741004 [Primary] |
| GS1 | 54987350741009 [Package] Contains: 04987350741004 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 | 2022-04-15 |
| Device Publish Date | 2022-04-07 |
On-Brand Devices [Progreat Lambda]
| 54987350741023 | Micro Catheter System |
| 54987350741009 | Micro Catheter System |
| 04987350740984 | 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 |
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