KyphoFlex™ KPA15A
GUDID 10884450845308
Merit Medical Systems, Inc.
Inflatable bone tamp| Primary Device ID | 10884450845308 |
| NIH Device Record Key | 01e8b512-fd7e-4035-bcb0-c977ad270efd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KyphoFlex™ |
| Version Model Number | Initial Release |
| Catalog Number | KPA15A |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450845301 [Primary] |
| GS1 | 10884450845308 [Package] Contains: 00884450845301 Package: [15 Units] In Commercial Distribution |
FDA Product Code
| HRX | Arthroscope |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
On-Brand Devices [KyphoFlex™]
| 00884450847046 | Initial Release |
| 10884450845322 | Initial Release |
| 10884450845315 | Initial Release |
| 10884450845308 | Initial Release |
Trademark Results [KyphoFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KYPHOFLEX 98524369 not registered Live/Pending |
MEDTRONIC HOLDING COMPANY SARL 2024-04-29 |
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