ARTICUL/EZE 136570000
GUDID 10603295034292
Articul/eze M-Spec FEMORAL HEAD Diameter 48mm +8.5 Offset 12/14 TAPER
DEPUY ORTHOPAEDICS, INC.
Metallic femoral head prosthesis| Primary Device ID | 10603295034292 |
| NIH Device Record Key | 43250345-f1df-442c-a1b6-2249674b12ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTICUL/EZE |
| Version Model Number | 1365-70-000 |
| Catalog Number | 136570000 |
| Company DUNS | 080506581 |
| Company Name | DEPUY ORTHOPAEDICS, 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)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295034292 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060031
FDA Product Code
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
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 | 2020-04-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [ARTICUL/EZE]
| 10603295034292 | Articul/eze M-Spec FEMORAL HEAD Diameter 48mm +8.5 Offset 12/14 TAPER |
| 10603295033974 | ARTICUL/EZE METAL ON METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +12 |
| 10603295033356 | ARTICUL/EZE FEMORAL HEAD Diameter 22.225mm +7 12/14 TAPER |
| 10603295033349 | ARTICUL/EZE FEMORAL HEAD Diameter 22.225mm +4 12/14 TAPER |
| 10603295099130 | M-SPEC ARTICUL/EZE 12/14 TRAY 40/44/48 |
Trademark Results [ARTICUL/EZE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTICUL/EZE 74077823 1644332 Live/Registered |
DEPUY SYNTHES, INC. 1990-07-05 |
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