AccessGUDID - DEVICE: NexGen® Legacy® Prolong® (00889024000650)

GUDID

Device Identifier (DI) Information

Brand Name: NexGen® Legacy® Prolong®
Version or Model: 00-5917-040-17
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-5917-040-17
Company Name: Zimmer, Inc.

Primary DI Number: 00889024000650
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?
46585	Tibial insert	An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P060037	000
P060037	009
P060037	027
P060037	040
P060037	055
P060037	059
P060037	060

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
Height: 17.00 Millimeter
Device Size Text, specify: Size D

Device Record Status

Public Device Record Key: 9c176d86-14f8-4881-b8a6-0da13308c715
Public Version Date: July 28, 2022
Public Version Number: 5
DI Record Publish Date: January 05, 2018