Product code LPZ
- Device name
- Container, Frozen Donor Tissue Storage
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021702 | CRYOBAG, MODEL CB | Origen Biomedical, Inc. | 2002-08-06 |
| K915471 | CRYOBAG | Janus Biomedical, Inc. | 1994-03-02 |
| K863872 | TAMPER HAMPER | Hydro-Med Products, Inc. | 1987-02-10 |
| K861761 | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE | Travenol Laboratories, S.A. | 1986-08-28 |
| K860511 | AMPU-PAK | Ammerman Medical Enterprises, Inc. | 1986-08-04 |
| K853663 | ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR | Travenol Laboratories, S.A. | 1986-04-09 |
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|---|---|---|---|
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| 10816203024104 | PermaLife™ Cell Culture Bag | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203024128 | PermaLife™ Cell Culture Bag | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203024340 | PermaLife™ Cell Culture Bag | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203024357 | PermaLife™ Cell Culture Bag | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023619 | PermaLife | ORIGEN BIOMEDICAL, INC. | 2021-11-15 |
| 10816203023626 | PermaLife | ORIGEN BIOMEDICAL, INC. | 2021-11-15 |
| 10816203023633 | PermaLife | ORIGEN BIOMEDICAL, INC. | 2021-11-15 |
| 10816203023602 | PermaLife | ORIGEN BIOMEDICAL, INC. | 2021-11-15 |
| 00817827023057 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023088 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023064 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023040 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023033 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023026 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827023019 | Cell Freeze | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00851739007026 | Biowy Freezing Bag | Biowy Corporation | 2021-05-24 |
| 00851739007033 | Biowy Freezing Bag | Biowy Corporation | 2021-05-24 |
| 00850301007792 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007808 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007815 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007822 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007839 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007846 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00850301007853 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00855495007320 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
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| 00855495007344 | Spectrum, Inc. | SPECTRUM, INC. | 2017-07-21 |
| 00816203021762 | PermaLife | ORIGEN BIOMEDICAL, INC. | 2016-05-27 |