AccessGUDID - DEVICE: Corin Unipolar Modular Head (05055343839638)

GUDID

Device Identifier (DI) Information

Brand Name: Corin Unipolar Modular Head
Version or Model: 576-02-140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 576-02-140
Company Name: CORIN LTD

Primary DI Number: 05055343839638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 295437313 *Terms of Use

Device Description: UNIPOLAR MOD HEADS

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:	Yes
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?
33175	Metallic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWL	Prosthesis, hip, hemi-, femoral, metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063791	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: d5c246a5-d84f-4139-b7e8-64d60ba9e8ba
Public Version Date: April 06, 2020
Public Version Number: 4
DI Record Publish Date: August 17, 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
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441285659866 ext: 2118
Email: rachel.king@coringroup.com

Phone: +441285659866 ext: 2203
Email: lucinda.gerber@coringroup.com

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