AccessGUDID - DEVICE: CEMENTED CUPS (08033390012836)

GUDID

Device Identifier (DI) Information

Brand Name: CEMENTED CUPS
Version or Model: Standard Cup
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5618.50.030
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390012836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Cemented cups (UHMWPE) Dia. 50 for head dia28mm

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?
34076	Polyethylene acetabulum prosthesis	A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of polyethylene (polyethylene cup); it may include fixation devices (e.g., screws) for attachment to the body.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112158	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Dia. 50mm For Heads 28mm

Device Record Status

Public Device Record Key: 9a0bf89c-f76a-4725-9c3f-adf1da3b3dd2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 31, 2015

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: No
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

[?]

No Customer Contact currently defined

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