| Primary Device ID | 00840075404453 |
| NIH Device Record Key | b39a4aae-832b-4858-9797-c1b7df4c6383 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraPEAK 293-GT AAV Supplement |
| Version Model Number | BP13-971C |
| Company DUNS | 609095955 |
| Company Name | Lonza Walkersville, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840075404453 [Primary] |
| KIT | Media And Components, Synthetic Cell And Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-31 |
| Device Publish Date | 2025-01-23 |
| 00840075404460 - GS2-N Low B12, No Hydrocortisone | 2025-05-20 |
| 00840075404477 - R34 Low B12 | 2025-05-20 |
| 00840075404484 - F30 Low B12, No Hydrocortisone | 2025-05-20 |
| 00840075404491 - R34 Low B12 | 2025-05-20 |
| 00840075404439 - X-VIVO 10 with Gentamycin and Phenol Red | 2025-01-31 |
| 00840075404446 - TheraPEAK 293-GT Medium | 2025-01-31 |
| 00840075404453 - TheraPEAK 293-GT AAV Supplement | 2025-01-31 |
| 00840075404453 - TheraPEAK 293-GT AAV Supplement | 2025-01-31 |
| 00840075404415 - UltraMDCK Serum Free Medium | 2024-11-27 |