| Primary Device ID | 00847536005266 |
| NIH Device Record Key | ba5e73f4-e094-4a82-968d-6e8d3f3e760a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperGlideTM |
| Version Model Number | 104-4315 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536005266 [Primary] |
| MJN | Catheter, intravascular occluding, temporary |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
[00847536005266]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-08-04 |
| 00847536005730 | 104-4530 HYPERGLIDE 5X30MM BALLOON SYS |
| 00847536005709 | 104-4530 HYPERGLIDE 5X30MM BALLOON SYS |
| 00847536005679 | 104-4520 HYPERGLIDE 5X20MM BALLOON SYS |
| 00847536005648 | 104-4520 HYPERGLIDE 5X20MM BALLOON SYS |
| 00847536005617 | 104-4515 HYPERGLIDE 5X15MM BALLOON SYS |
| 00847536005587 | 104-4515 HYPERGLIDE 5X15MM BALLOON SYS |
| 00847536005297 | 104-4315 HYPERGLIDE 3X15MM BALLOON SYS |
| 00847536005266 | 104-4315 HYPERGLIDE 3X15MM BALLOON SYS |
| 00847536005235 | 104-4310 HYPERGLIDE 3X10MM BALLOON SYS |
| 00847536005204 | 104-4310 HYPERGLIDE 3X10MM BALLOON SYS |
| 00847536005105 | 104-4132 HYPERGLIDE 4X30MM BALLOON SYS |
| 00847536005075 | 104-4132 HYPERGLIDE 4X30MM BALLOON SYS |
| 00847536005020 | 104-4127 HYPERGLIDE 4X20MM BALLOON SYS |
| 00847536004986 | 104-4127 HYPERGLIDE 4X20MM BALLOON SYS |
| 00847536004948 | 104-4113 HYPERGLIDE 4X10MM BALLOON SYS |
| 00847536004863 | 104-4112 HYPERGLIDE 4X15MM BALLOON SYS |