CEMENTON 431367
GUDID 00880304682979
Biomet Orthopedics, LLC
Orthopaedic cement spacer mould| Primary Device ID | 00880304682979 |
| NIH Device Record Key | 2ed90e25-50ca-4a5d-829b-8b66215861b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CEMENTON |
| Version Model Number | 431367 |
| Catalog Number | 431367 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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)348-9500 |
| customerservice@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304682979 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142933
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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 | 2019-09-23 |
| Device Publish Date | 2016-09-26 |
On-Brand Devices [CEMENTON]
| 00880304683037 | 431391 |
| 00880304683020 | 431387 |
| 00880304683013 | 431383 |
| 00880304683006 | 431379 |
| 00880304682993 | 431375 |
| 00880304682986 | 431371 |
| 00880304682979 | 431367 |
| 00880304682962 | 431363 |
| 00880304682955 | 431359 |
| 00880304681262 | 431291 |
| 00880304681255 | 431287 |
| 00880304681248 | 431283 |
| 00880304681231 | 431279 |
| 00880304681224 | 431275 |
| 00880304681217 | 431271 |
| 00880304681200 | 431267 |
| 00880304681194 | 431263 |
| 00880304681187 | 431259 |
Trademark Results [CEMENTON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CEMENTON 86126664 5086968 Live/Registered |
Biomet Manufacturing, LLC 2013-11-22 |
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