Primary Device ID | 00860011334705 |
NIH Device Record Key | 7e4de8a4-b3f4-4bd3-9574-248db8641c1b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Planatome® |
Version Model Number | GY-10 |
Company DUNS | 080998543 |
Company Name | Planatome, 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 Issuing Agency | Device ID |
---|---|
GS1 | 00860003857885 [Primary] |
GS1 | 00860011334705 [Package] Contains: 00860003857885 Package: Box [10 Units] In Commercial Distribution |
GS1 | 00860011334729 [Package] Contains: 00860003857885 Package: Box [50 Units] In Commercial Distribution |
GES | Blade, Scalpel |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-25 |
Device Publish Date | 2024-04-17 |
00860003857854 | Planatome Ultra-Fine #15 Scalpel |
00860003857830 | Planatome Ultra-Fine #10 Scalpel |
00860011334712 | Planatome Gray #15 Scalpel Blade |
00860011334705 | Planatome Gray #10 Scalpel Blade |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PLANATOME 87052733 not registered Live/Pending |
ENTREPIX MEDICAL, LLC 2016-05-27 |