Durasul®
GUDID 00889024169012
Zimmer, Inc.
Non-constrained polyethylene acetabular liner| Primary Device ID | 00889024169012 |
| NIH Device Record Key | f7336324-5908-454c-b0bf-585705574920 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durasul® |
| Version Model Number | 4376-44-069 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com |
Device Dimensions
| Lumen/Inner Diameter | 44 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024169012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993259
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-23 |
On-Brand Devices [Durasul®]
Trademark Results [Durasul]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURASUL 75559888 2466130 Live/Registered |
ZIMMER, INC. 1998-09-25 |
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