Sphere-9™ Catheter

GUDID 00763000973391

Cardiac radio-frequency ablation system catheter

Primary Device ID	00763000973391
NIH Device Record Key	d199a8a4-fd7a-44a6-9945-36e6414f1a6c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sphere-9™ Catheter
Version Model Number	AFR-00001
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	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

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry

Device Issuing Agency	Device ID
GS1	00763000973391 [Primary]

OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Steralize Prior To Use	false
Device Is Sterile	true

00763000973391	CATHETER AFR-00001 SPHERE 9 Q-US AFR
00763000973506	CATHETER AFR-00001 SPHERE 9 US

Mark Image Registration \| Serial	Company Trademark Application Date
SPHERE-9 97821482 not registered Live/Pending	Affera, Inc 2023-03-03