| Primary Device ID | 04048266025463 |
| NIH Device Record Key | 4a2d333d-3e2b-47ab-9dfc-2fe040f0377d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioBall DELTA™ Ceramic Head |
| Version Model Number | 32 |
| Catalog Number | HM50032 |
| Company DUNS | 313267265 |
| Company Name | Merete GmbH |
| 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 | true |
| 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 |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266025463 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2015-10-15 |
| 04048266025470 | ISO 6474-2 sterile |
| 04048266025463 | ISO 6474-2 sterile |
| 04048266025456 | ISO 6474-2 sterile |