FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Disposable Vein Hook
DI: M20678000
·
Model: 7800
·
Vascular Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Disposable Vein Hook
- Primary DI
- M20678000
- Version / Model
- 7800
- Company Name
- Vascular Solutions, Inc.
- Labeler DUNS
- 008999906
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 3
- Public Version Date
- 2022-02-22
- Public Version Status
- Update
- Public Device Record Key
- c7e34410-3f3b-4ee0-8b93-5855cdacf370
- Distribution End Date
- 2021-04-11
Device Description
The Disposable Vein Hook is intended for single patient use for the treatment of superficial varicose veins and varicosities associated with superficial reflux and incompetence of the Great Saphenous Vein in the lower extremities.
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
- Yes
- 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 |
|---|---|---|---|---|
| GAJ | Stripper, Vein, Disposable | General, Plastic Surgery | 878.4800 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | M20678000 | HIBCC | ||||
| Package | M20678001 | HIBCC | Box | 10 | Not in Commercial Distribution | 2021-04-11 |
Customer Contacts
- Phone
- 888-240-6001
- [email protected]