FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tru-Incise Valvulotome with Interchangeable Heads
DI: H862TIVH300
·
Model: TIVH30
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Tru-Incise Valvulotome with Interchangeable Heads
- Primary DI
- H862TIVH300
- Version / Model
- TIVH30
- Catalog Number
- TIVH30
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2019-09-18
- Public Version Status
- Update
- Public Device Record Key
- fd6d83a8-85c8-4391-a99e-99e3a4930334
- Distribution End Date
- 2019-09-17
Device Description
Tru-Incise 3mm Cutting Head
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
- Yes
- 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 |
|---|---|---|---|---|
| MGZ | Valvulotome | Cardiovascular | 870.4885 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32321 | Vein stripper, single-use | A sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H862TIVH302 | HIBCC | Shipper | 10 | Not in Commercial Distribution | 2019-09-17 |
| Package | H862TIVH301 | HIBCC | Dispenser | 1 | Not in Commercial Distribution | 2019-09-17 |
| Primary | H862TIVH300 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930011 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3 | Millimeter |