| Primary Device ID | 00847536005822 |
| NIH Device Record Key | 266cf135-f57d-4fab-9049-f906fcec93c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperFormTM |
| Version Model Number | 104-4770 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, Inc. |
| 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 | true |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536005822 [Primary] |
| MJN | Catheter, intravascular occluding, temporary |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
[00847536005822]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-04-05 |
| 00847536005853 | 104-4770 HYPERFORM 7X7MM BALLOON SYS |
| 00847536005822 | 104-4770 HYPERFORM 7X7MM BALLOON SYS |
| 00847536005792 | 104-4715 HYPERFORM 7X15MM BALLOON SYS |
| 00847536005761 | 104-4715 HYPERFORM 7X15MM BALLOON SYS |
| 00847536005549 | 104-4470 HYPERFORM 4X7MM BALLOON SYS |
| 00847536005501 | 104-4470 HYPERFORM 4X7MM BALLOON SYS |
| 00847536005471 | 104-4420 HYPERFORM 4X20MM BALLOON SYS |
| 00847536005419 | 104-4415 HYPERFORM 4X15MM BALLOON SYS |
| 00847536005358 | 104-4370 HYPERFORM 3X7MM BALLOON SYS |
| 00847536005327 | 104-4370 HYPERFORM 3X7MM BALLOON SYS |
| 00847536005174 | 104-4153 HYPERFORM 3X15MM BALLOON SYS |
| 00847536005143 | 104-4153 HYPERFORM 3X15MM BALLOON SYS |