Planatome®
GUDID 00860003534687
Planatome #15 Scalpel
ENTREPIX MEDICAL, LLC
Scalpel blade, single-use| Primary Device ID | 00860003534687 |
| NIH Device Record Key | be21eef2-5e92-4747-93d7-e224c83c34ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Planatome® |
| Version Model Number | PL-15 |
| Company DUNS | 080998543 |
| Company Name | ENTREPIX MEDICAL, LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
| Weight | 0.413 Gram |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003534625 [Primary] |
| GS1 | 00860003534687 [Package] Contains: 00860003534625 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00860003534694 [Package] Contains: 00860003534625 Package: Box [50 Units] In Commercial Distribution |
FDA Product Code
| GES | Blade, Scalpel |
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 | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
On-Brand Devices [Planatome®]
| 00860003857809 | Planatome #15C Scalpel |
| 00860003534687 | Planatome #15 Scalpel |
| 00860003534663 | Planatome #11 Scalpel |
| 00860003534601 | Planatome #10 Scalpel |
Trademark Results [Planatome]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLANATOME 87052733 not registered Live/Pending |
ENTREPIX MEDICAL, LLC 2016-05-27 |
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