Durasul® 4380-28-059
GUDID 00889024169548
Zimmer, Inc.
Constrained polyethylene acetabular liner| Primary Device ID | 00889024169548 |
| NIH Device Record Key | 9988f926-f261-46da-9540-2ac4ef6ae5cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Durasul® |
| Version Model Number | 4380-28-059 |
| Catalog Number | 4380-28-059 |
| 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 | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024169548 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030923
FDA Product Code
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2015-10-23 |
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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