AccessGUDID - DEVICE: Uniglide Unicondylar Knee Prosthesis (05055196908123)

GUDID

Device Identifier (DI) Information

Brand Name: Uniglide Unicondylar Knee Prosthesis
Version or Model: BC8K-2G01-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BC8K-2G01-000
Company Name: CORIN LTD

Primary DI Number: 05055196908123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 295437313 *Terms of Use

Device Description: C-ARM IMPACTOR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32865	Orthopaedic implant driver	A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRY	PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050764	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 649e3fc8-92bc-4611-b011-b1dafd2d67a9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 17, 2016