DEVICE: NA (10705034719733)
Device Identifier (DI) Information
NA
03.632.307
In Commercial Distribution
03632307
Synthes GmbH
03.632.307
In Commercial Distribution
03632307
Synthes GmbH
TROCAR FOR NAVIGABLE CANNULATED AWL/PROBES/TAPS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
47457 | Orthopaedic trocar blade, reusable |
A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAW | Neurological stereotaxic Instrument |
OLO | Orthopedic stereotaxic instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122211 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
44a8ff80-8c07-42e2-b1e7-55f661ac3f1a
June 01, 2022
4
June 30, 2016
June 01, 2022
4
June 30, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | H981036323070 |
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)255-2500
xx@xx.xx
xx@xx.xx