| Primary Device ID | 05407008487003 |
| NIH Device Record Key | 60d7f170-c405-440a-9c41-3f43b85bf465 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FrostAway™ |
| Version Model Number | FrostAway Pen cartridges |
| Catalog Number | FROSTAWAYPEN-CA |
| Company DUNS | 370212933 |
| Company Name | H & O Equipments SA |
| Device Count | 6 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com | |
| Phone | 1-888-248-2838 |
| cryoprobe@ho-equipments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05407008487003 [Unit of Use] |
| GS1 | 15407008487017 [Primary] |
| GEH | Unit, Cryosurgical, Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-26 |
| Device Publish Date | 2025-05-18 |
| 05407008487003 | FrostAway Pen cartridges |
| 15407008487000 | FrostAway Pen |