| Primary Device ID | 00856331006132 |
| NIH Device Record Key | 0eb20ddd-acc8-4baf-8b24-626cb8af24ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CryoDose H |
| Version Model Number | 170102 |
| Catalog Number | 170102 |
| Company DUNS | 078797666 |
| Company Name | NUANCE MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com | |
| Phone | +1(760)585-4849 |
| george@cryodose.com |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Total Volume | 88 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Storage Environment Temperature | Between 0 and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *do not store near direct heat source |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856331006132 [Primary] |
| GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-03 |
| 00856331006132 | CryoDose H 2 canister only |
| 00856331006125 | CryoDose H 1 canister only |
| 00856331006118 | CryoDose H 1 kit w/ 1 canister, 20/ 2mm buds, 30/ 5mm buds |
| 00856331006101 | CryoDose H 1 kit w/ 1 canister, 40/ 5mm buds |
| 00856331006095 | CryoDose H 1 kit w/ 1 canister, 40/ 2mm buds |
| 00856331006088 | CryoDose H 1 kit w/ 2 canisters, 30/ 2mm buds, 40/ 5mm buds |