FDA UDI
In Commercial Distribution
🇺🇸 United States
InThrill Thrombectomy Catheter
DI: 00810123710126
·
Model: 43-102
·
Inari Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- InThrill Thrombectomy Catheter
- Primary DI
- 00810123710126
- Version / Model
- 43-102
- Catalog Number
- 43-102
- Company Name
- Inari Medical, Inc.
- Labeler DUNS
- 076827459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 9a8ea348-3729-4e97-bbf6-1c965cc79f0c
Device Description
InThrill Thrombectomy Catheter (AS-01312)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61179 | Electronic occlusion spectacles | A battery-powered ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes (e.g., presbyopia). It is in the form of spectacles with lenses that can independently be made opaque electronically, so that the stronger eye is occluded to promote use of the weaker eye. It is intended to be used for short intervals (e.g., 15 – 30 minutes), typically at home, and is normally available [non-prescription] over-the-counter (OTC). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810123710126 | GS1 | ||||
| Previous | 00850291007352 | GS1 |
Customer Contacts
- Phone
- 18779234747
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250421 | 000 |