GuideBlade AMB 1746-10

GUDID 00860000561907

Scalpel, single-use

Primary Device ID	00860000561907
NIH Device Record Key	27150405-5136-46cd-a5fa-08a850a803bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	GuideBlade
Version Model Number	AMB 1746
Catalog Number	AMB 1746-10
Company DUNS	117065827
Company Name	Ambitus Medical Supplies LLC
Device Count	10
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	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860000561907 [Primary]
GS1	10860000561904 [Unit of Use]
GS1	20860000561901 [Package] Package: Inner Carton [25 Units] In Commercial Distribution
GS1	30860000561908 [Package] Contains: 20860000561901 Package: Case [2 Units] In Commercial Distribution

GDX	Scalpel, One-Piece

Steralize Prior To Use	false
Device Is Sterile	true

20860000561918	GuideBlade, non-sterile, intended for inclusion in kits
00860000561907	Sterile GuideBlade

Mark Image Registration \| Serial	Company Trademark Application Date
GUIDEBLADE 86683037 5087636 Live/Registered	Ambitus Medical Supply LLC 2015-07-03
GUIDEBLADE 86284384 not registered Dead/Abandoned	Ambitus Medical Supply LLC 2014-05-17