Planatome®

GUDID 00860003857830

Manual scalpel blade, single-use

Primary Device ID	00860003857830
NIH Device Record Key	2257f27f-e62e-4a13-8959-8f39d7965650
Commercial Distribution Status	In Commercial Distribution
Brand Name	Planatome®
Version Model Number	UF-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	00860003857823 [Primary]
GS1	00860003857830 [Package] Contains: 00860003857823 Package: Box [50 Units] In Commercial Distribution
GS1	00860003857861 [Package] Contains: 00860003857823 Package: Box [10 Units] In Commercial Distribution

GES	Blade, Scalpel

Steralize Prior To Use	false
Device Is Sterile	true

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