AccuPlate® Patient-Specific Plate ZB-PLT007
GUDID 00810007630939
MANDIBLE, 2.8 DOUBLE ANGLE
Medcad
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00810007630939 |
| NIH Device Record Key | 9c5e4245-d87d-4fb3-8628-0ac84ab6cf26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuPlate® Patient-Specific Plate |
| Version Model Number | ZB-PLT007 |
| Catalog Number | ZB-PLT007 |
| Company DUNS | 144723868 |
| Company Name | Medcad |
| 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 | true |
| 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
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com | |
| Phone | (214) 453-8864 |
| support@medcad.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810007630939 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193280
FDA Product Code
| JEY | Plate, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
[00810007630939]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-13 |
| Device Publish Date | 2022-05-05 |
On-Brand Devices [AccuPlate® Patient-Specific Plate]
| 00810007630984 | MANDIBLE, 2.6 FULL |
| 00810007630977 | MANDIBLE, 2.6 DOUBLE ANGLE |
| 00810007630960 | MANDIBLE, 2.6 HEMI |
| 00810007630953 | MANDIBLE, 2.6 STRAIGHT |
| 00810007630946 | MANDIBLE, 2.8 FULL |
| 00810007630939 | MANDIBLE, 2.8 DOUBLE ANGLE |
| 00810007630922 | MANDIBLE, 2.8 HEMI |
| 00810007630915 | MANDIBLE, 2.8 STRAIGHT |
| 00810007630908 | MANDIBLE, 2.0 FULL |
| 00810007630892 | MANDIBLE, 2.0 DOUBLE ANGLE |
| 00810007630885 | MANDIBLE, 2.0 HEMI |
| 00810007630878 | MANDIBLE, 2.0 STRAIGHT |
Trademark Results [AccuPlate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUPLATE 87263836 5392792 Live/Registered |
Vanduzen Inc. 2016-12-09 |
 ACCUPLATE 75075759 not registered Dead/Abandoned |
Bayer Corporation 1996-03-20 |
 ACCUPLATE 73679042 1525176 Dead/Cancelled |
ICL SCIENTIFIC, INC. 1987-08-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.