FDA UDI
In Commercial Distribution
🇺🇸 United States
Liberant™
DI: 00763000998615
·
Model: LMT-CT8S
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Liberant™
- Primary DI
- 00763000998615
- Version / Model
- LMT-CT8S
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-16
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- 38f1101a-27fc-4835-ae1a-8e96322043b3
Device Description
CATHETER LMT-CT8S LIBERANT 8S
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEW | Peripheral mechanical thrombectomy with aspiration | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66971 | Thrombectomy suction catheterization kit | A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000998615 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250787 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Dilator Outer Diameter: 2.16 MM | ||
| Device Size Text, specify | Clotbuster Outer Diameter: 1.56 MM | ||
| Device Size Text, specify | French Size: 8F Short | ||
| Catheter Inner Diameter | 2.24 | Millimeter | |
| Catheter Length | 50.0 | Centimeter | |
| Outer Diameter | 2.8 | Millimeter | |
| Device Size Text, specify | Dilator Length: 67 CM | ||
| Device Size Text, specify | Clotbuster Length: 66CM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry