| Primary Device ID | M3848135161 |
| NIH Device Record Key | bf83a213-41e6-4380-b6eb-5841d61f9eef |
| Commercial Distribution Discontinuation | 2022-02-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Bioplate@ |
| Version Model Number | 81-3516 |
| Catalog Number | 81-3516 |
| Company DUNS | 838734093 |
| Company Name | Bioplate, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M3848135160 [Primary] |
| HIBCC | M3848135161 [Package] Contains: M3848135160 Package: [6 Units] Discontinued: 2022-02-01 Not in Commercial Distribution |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-02-02 |
| Device Publish Date | 2015-12-03 |
| M384P3ST16860 | Straight Plate - Ø1.9 mm - 16 hole - 86 mm |
| M384P3SB04200 | Straight Plate - Ø1.9 mm - 4 hole - 20 mm |
| M384P3SB0212051 | Straight Plate - Ø1.9 mm - 2 hole - 12 mm [5 PK] |
| M384P2SB04210 | Xpress ® Straight Plate - Ø1.5 mm - 4 hole - 21 mm |
| M3848135960 | 5-Tab Zip Implant - 20 mm |
| M384813595US0 | 5-Tab Zip Implant - 16 mm |
| M3848135950 | 5-Tab Zip Implant - 16 mm |
| M3848135940 | 5-Tab Zip Implant - 12 mm |
| M3848135181 | Zip® Implant - 20 mm (STERILE) [6 PK] |
| M3848135171 | Zip® Implant - 16 mm (STERILE) [6 PK] |
| M3848135161 | Zip® Implant - 12 mm (STERILE) [6 PK] |