DEVICE: ONCONTROL (10841156108434)
Device Identifier (DI) Information
ONCONTROL
IPN919011
In Commercial Distribution
9401
TELEFLEX INCORPORATED
IPN919011
In Commercial Distribution
9401
TELEFLEX INCORPORATED
OnControl® Power Driver
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
62075 | Intraosseous-access handpiece, infusion, electric |
A hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | INSTRUMENT, BIOPSY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e687e75b-2e66-45a1-bb28-7391851176e0
July 25, 2023
2
January 21, 2022
July 25, 2023
2
January 21, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20841156108431 | 1 | 10841156108434 | 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(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM