Palium PL
GUDID 08056138586109
REUSABLE AUTOMATIC BIOPSY INSTRUMENT
MDL SRL
Biopsy gun handpiece| Primary Device ID | 08056138586109 |
| NIH Device Record Key | 40e67c55-e4a3-475e-a4ef-2a730121fc94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Palium |
| Version Model Number | PL |
| Catalog Number | PL |
| Company DUNS | 447228586 |
| Company Name | MDL SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056138586109 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160316
FDA Product Code
| FCG | Biopsy Needle |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
[08056138586109]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
On-Brand Devices [Palium]
| 08052440107018 | AUTOMATIC REUSABLE GUN FOR SOFT TISSUES BIOPSY, PALIUM TYPE |
| 08056138586109 | REUSABLE AUTOMATIC BIOPSY INSTRUMENT |
Trademark Results [Palium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALIUM 78485842 not registered Dead/Abandoned |
Karen G Sloma 2004-09-18 |
 PALIUM 78282787 not registered Dead/Abandoned |
Sloma, Karen G. 2003-08-04 |
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