Biosensors Embolectomy Catheter 23-000004-03

GUDID 08886483504356

BIOPTIMAL INTERNATIONAL PTE. LTD.

Thrombectomy balloon catheter
Primary Device ID08886483504356
NIH Device Record Key5c293303-5d81-456f-a583-20c90d2d1d5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosensors Embolectomy Catheter
Version Model NumberEL 1480 (VP CAP)
Catalog Number23-000004-03
Company DUNS595182247
Company NameBIOPTIMAL INTERNATIONAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places

Device Identifiers

Device Issuing AgencyDevice ID
GS108886483504356 [Primary]

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01

On-Brand Devices [Biosensors Embolectomy Catheter]

58888893235122EL3380
58888893235108EL3280
58888893235092EL3260
58888893235054EL 1780 (VP CAP)
58888893235047EL 1680 (VP CAP)
58888893235030EL 1580 (VP CAP)
58888893235016EL 1480 (VP CAP)
68888893235006EL1440 (VP CAP)
08886483507531EL3380
08886483507517EL3280
08886483507500EL3260
08886483504394EL 1780 (VP CAP)
08886483504387EL 1680 (VP CAP)
08886483504370EL 1580 (VP CAP)
08886483504356EL 1480 (VP CAP)
08886483504349EL1440 (VP CAP)

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