ULTRA Detach

GUDID 00818053024351

The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system.

BALT USA LLC

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Primary Device ID00818053024351
NIH Device Record Key235e1e54-186f-40c2-a06c-f10945840c8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRA Detach
Version Model NumberULTRA
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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

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.
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.
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
GS100818053024351 [Primary]

FDA Product Code

HCGDevice, Neurovascular Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-11
Device Publish Date2019-01-11

On-Brand Devices [ULTRA Detach]

00818053024351The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separat
00818053029639The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separat

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