DEVICE: Uniglide Unicondylar Knee Prosthesis (05055196908994)

Download: XML | JSON

Device Identifier (DI) Information

Uniglide Unicondylar Knee Prosthesis
BC8J-9G01-000
BC8J-9G01-000
CORIN LTD
05055196908994
GS1
1
SPERICAL REAMER-12MM SPANNER
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bone-resection orthopaedic reamer, reusable An orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
August 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

[?]
+441285659866 2203
lucinda.gerber@coringroup.com
+441285659866 2118
rachel.king@coringroup.com
CLOSE