FDA UDI
In Commercial Distribution
🇺🇸 United States
Progreat Lambda
DI: 04987350741028
·
Model: CC*M1916DN
·
TERUMO CLINICAL SUPPLY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Progreat Lambda
- Primary DI
- 04987350741028
- Version / Model
- CC*M1916DN
- Catalog Number
- CCM1916DN
- Company Name
- TERUMO CLINICAL SUPPLY CO., LTD.
- Labeler DUNS
- 691034748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-07
- Public Version
- 1
- Public Version Date
- 2022-04-15
- Public Version Status
- New
- Public Device Record Key
- fa3a6f42-2072-4fb1-8b26-ff12fe8ffde1
Device Description
Micro Catheter System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10691 | Vascular microcatheter | A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54987350741023 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 04987350741028 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211078 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 165 | Centimeter | |
| Catheter Inner Diameter | 0.48 | Millimeter | |
| Outer Diameter | 0.64 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile. Keep dry. Keep away from sunlight.