AccessGUDID - DEVICE: POLARCUPTM (07611996096217)

GUDID

Brand Name: POLARCUPTM
Version or Model: 75017198
Catalog Number: 75017198
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996096217
Issuing Agency: GS1
Device Count: 1

Device Description: POLARCUP SHELL 51 CEMENTED

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

GMDN Preferred Term Name	GMDN Definition
Acetabular shell	A sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Product Code	Product Code Name
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 29, 2015
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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

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

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

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

Phone: +1(978)269-4663
Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM