Prestige Coil System

GUDID 00810068567311

The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.

BALT USA LLC

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil
Primary Device ID00810068567311
NIH Device Record Keyb20f38f3-9756-4fe3-b696-72cb1a59d25a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrestige Coil System
Version Model NumberPRES0153CXPPLT
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810068567311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-02
Device Publish Date2022-07-25

On-Brand Devices [Prestige Coil System]

00818053027109The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027758The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027710The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027703The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027697The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027680The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027673The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027666The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027659The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027642The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027635The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027628The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027611The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027604The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053023620The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027741The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027734The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027727The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027598The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027581The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027574The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027567The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027550The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027543The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027536The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027529The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027512The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027505The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027499The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027482The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027475The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027468The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027451The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027444The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027437The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027420The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027413The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027406The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027390The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027383The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027376The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027369The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027352The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027345The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027338The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027321The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027314The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027307The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027291The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
00818053027284The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral va
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