TruDi NAV Suction TDNS000Z

GUDID 80705031245876

TruDi NAV Suction, 0° - 1PK

ACCLARENT, INC.

Electromagnetic/optical surgical navigation device tracking system

Primary Device ID	80705031245876
NIH Device Record Key	8c1ab2c3-4015-4367-8e31-eb5f67731eb6
Commercial Distribution Status	In Commercial Distribution
Brand Name	TruDi NAV Suction
Version Model Number	TDNS000Z
Catalog Number	TDNS000Z
Company DUNS	361092450
Company Name	ACCLARENT, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Customer Support Contacts

Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx
Phone	+1(877)775-2789
Email	xxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031245877 [Primary]
GS1	80705031245876 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180948

FDA Product Code

PGW	Ear, Nose, and Throat Stereotaxic Instrument