DEVICE: Tru-Incise Valvulotome with Interchangeable Heads (H862TIVK20300)
Device Identifier (DI) Information
Tru-Incise Valvulotome with Interchangeable Heads
TIVK2030
Not in Commercial Distribution
TIVK2030
URESIL, LLC
TIVK2030
Not in Commercial Distribution
TIVK2030
URESIL, LLC
Tru-Incise Valvulotome
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MGZ | Valvulotome |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K930011 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 94 Centimeter |
Device Record Status
906d4822-827a-45c5-a770-aa1d51ba5eeb
September 12, 2019
4
August 31, 2016
September 12, 2019
4
August 31, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H862TIVK20302 | 10 | H862TIVK20301 | 2019-09-11 | Not in Commercial Distribution | Shipper |
H862TIVK20301 | 1 | H862TIVK20300 | 2019-09-11 | Not in Commercial Distribution | Dispenser |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-538-7374
sales@uresil.com
sales@uresil.com