Progreat Lambda CCM1916AN

GUDID 54987350741009

Micro Catheter System

TERUMO CLINICAL SUPPLY CO., LTD.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter
Primary Device ID54987350741009
NIH Device Record Keyd118481f-089a-4856-a368-22943033af8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProgreat Lambda
Version Model NumberCC*M1916AN
Catalog NumberCCM1916AN
Company DUNS691034748
Company NameTERUMO CLINICAL SUPPLY CO., 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter
Length165 Centimeter
Catheter Inner Diameter0.48 Millimeter
Outer Diameter0.64 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS104987350741004 [Primary]
GS154987350741009 [Package]
Contains: 04987350741004
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-15
Device Publish Date2022-04-07

On-Brand Devices [Progreat Lambda]

54987350741023Micro Catheter System
54987350741009Micro Catheter System
04987350740984Micro Catheter System

Trademark Results [Progreat Lambda]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROGREAT LAMBDA
PROGREAT LAMBDA
88464196 not registered Live/Pending
Terumo Kabushiki Kaisha
2019-06-07
PROGREAT LAMBDA
PROGREAT LAMBDA
88464154 not registered Live/Pending
Terumo Kabushiki Kaisha
2019-06-07
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