| Primary Device ID | 20841268104444 |
| NIH Device Record Key | 58efa816-28ef-4d7c-bd27-df746f032b3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TVS LPA |
| Version Model Number | KIT-071-03 |
| Catalog Number | LPA440SN |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268104440 [Primary] |
| GS1 | 10841268104447 [Package] Contains: 00841268104440 Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20841268104444 [Package] Contains: 10841268104447 Package: Shipper Box [25 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
[20841268104444]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2017-08-09 |
| 20841268107339 | TVS LPA |
| 20841268107292 | TVS LPA |
| 20841268107285 | TVS LPA |
| 20841268106950 | TVS LPA |
| 20841268106943 | TVS LPA |
| 20841268106905 | TVS LPA |
| 20841268106899 | TVS LPA |
| 20841268104444 | TVS LPA |
| 20841268104437 | TVS LPA |
| 20841268103034 | TVS LPA |
| 00841268103023 | TVS LPA |
| 10841268110127 | TVS LPA |
| 10841268110097 | TVS LPA |