AccessGUDID - DEVICE: Continuum® Trilogy® Allofit® Longevity® (00889024152076)

GUDID

Device Identifier (DI) Information

Brand Name: Continuum® Trilogy® Allofit® Longevity®
Version or Model: 00-8758-023-36
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-8758-023-36
Company Name: Zimmer, Inc.

Primary DI Number: 00889024152076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056038268 *Terms of Use

Device Description: No description.

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?
44362	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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101730	000
K200823	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
Lumen/Inner Diameter: 36 Millimeter
Device Size Text, specify: Size V V

Device Record Status

Public Device Record Key: f5d8b088-ab80-4457-bbee-f0c1c8cef256
Public Version Date: August 31, 2020
Public Version Number: 5
DI Record Publish Date: September 17, 2015