AccessGUDID - DEVICE: Continuum® Trilogy® Allofit® Vivacit-E® (00889024155428)

GUDID

Device Identifier (DI) Information

Brand Name: Continuum® Trilogy® Allofit® Vivacit-E®
Version or Model: 00-8851-023-36
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-8851-023-36
Company Name: Zimmer, Inc.

Primary DI Number: 00889024155428
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?
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
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
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 [?]
K120370	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: ef632ab1-11a1-409b-9d54-f1f2f9279a7f
Public Version Date: June 10, 2020
Public Version Number: 4
DI Record Publish Date: September 17, 2015