DEVICE: S 60-K (04035479145071)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
62919 | Vascular catheter stylet |
A thin sterile wire intended to be inserted within the lumen of a vascular catheter [e.g., peripheraly inserted venous catheter (PICC)] to stiffen and/or maintain the shape of the catheter to facilitate insertion; it is not intended for introduction into the coronary vasculature. It may be magnetic to enable use with a magnetic tracking system. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRB | STYLET, CATHETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191469 | 000 |
P820076 | 021 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 41 and 131 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c867bd25-6453-4d3c-9e66-e30a9cf49ee5
August 09, 2019
4
August 15, 2014
August 09, 2019
4
August 15, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04035479000493 | 10 | 04035479145071 | In Commercial Distribution | case |
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(888)345-0374
jon.brumbaugh@biotronik.com
jon.brumbaugh@biotronik.com