| Primary Device ID | 00195278925428 |
| NIH Device Record Key | 87452dc6-1225-4432-a4b6-0956d97d82b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pristina Paddle |
| Version Model Number | SLD LS |
| Company DUNS | 266062561 |
| Company Name | GE MEDICAL SYSTEMS |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278925428 [Primary] |
| FMQ | Restraint, Protective |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-17 |
| Device Publish Date | 2025-01-09 |
| 00195278330390 | Sliding 19x23 flexible paddle - Labelled |
| 00195278527905 | Sliding square spot paddle - Labelled |
| 00195278527943 | Sliding 2D Loc 19X23 paddle - Labelled |
| 00195278527936 | Sliding round spot paddle - Labelled |
| 00195278527929 | Sliding 10x23 Implant Paddle - Labelled |
| 00195278527912 | 24x29 FLEXIBLE PADDLE - Labelled |
| 00195278527882 | 24x29 STANDARD PADDLE - labelled |
| 00195278527950 | SLIDING 19X23 PADDLE - labelled |
| 00195278527899 | Sliding 2D Loc 19x23 Perforated Paddle- Labelled |
| 00195278925428 | Small Square presurgical localization paddle - Labelled |