DEVICE: Bipolar Head (08033390032162)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Bipolar Head
Femoral Head Gauge
In Commercial Distribution
9050.10.003
LIMACORPORATE SPA
08033390032162
GS1

1
432066322 *Terms of Use
Femoral Head Gauge Dia.51-54mm
CLOSE

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?
46479 Surgical implant template, reusable
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K112158 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Dia.51-54mm
CLOSE

Device Record Status
341c54cb-3f6e-4715-a70f-3aa0d6447b94
July 06, 2018
4
June 17, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE