AccessGUDID - DEVICE: PINNACLE ALTRX (10603295016328)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE ALTRX
Version or Model: 1221-36-052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 122136052
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295016328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: PINNACLE HIP SOLUTIONS ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 36mm ID 52mm OD

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Active	true

[?]

FDA Product Code

Product Code	Product Code Name
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

[?]

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
No storage/handling found

[?]

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

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

Customer Contact

[?]

DEVICE: PINNACLE ALTRX (10603295016328)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact