ELM HP PTA

GUDID 05391518031767

ELM HP PTA 8mm x 80mm x 75cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391518031767
NIH Device Record Key0ff24c46-1fa9-4b7b-ba7e-8e7e5207f9dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameELM HP PTA
Version Model NumberELM880L
Company DUNS985021909
Company NameCREAGH MEDICAL LIMITED
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

Device Dimensions

Length80 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391518031767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [ELM HP PTA]

05391518031798ELM HP PTA 12mm x 40mm x 75cm
05391518031781ELM HP PTA 10mm x 40mm x 75cm
05391518031774ELM HP PTA 9mm x 40mm x 75cm
05391518031767ELM HP PTA 8mm x 80mm x 75cm
05391518031750ELM HP PTA 8mm x 60mm x 75cm
05391518031743ELM HP PTA 8mm x 40mm x 75cm
05391518031736ELM HP PTA 8mm x 20mm x 75cm
05391518031729ELM HP PTA 7mm x 100mm x 75cm
05391518031712ELM HP PTA 7mm x 60mm x 75cm
05391518031705ELM HP PTA 7mm x 40mm x 75cm
05391518031699ELM HP PTA 7mm x 20mm x 75cm
05391518031682ELM HP PTA 6mm x 100mm x 75cm
05391518031675ELM HP PTA 6mm x 60mm x 75cm
05391518031668ELM HP PTA 6mm x 40mm x 75cm
05391518031651ELM HP PTA 6mm x 20mm x 75cm
05391518031644ELM HP PTA 5mm x 60mm x 75cm
05391518031637ELM HP PTA 5mm x 40mm x 75cm
05391518031620ELM HP PTA 5mm x 20mm x 75cm
05391518031613ELM HP PTA 4mm x 40mm x 75cm
05391518031606ELM HP PTA 4mm x 20mm x 75cm
05391518031590ELM HP PTA 3mm x 40mm x 75cm
05391518031583ELM HP PTA 12mm x 40mm x 40cm
05391518031576ELM HP PTA 10mm x 40mm x 40cm
05391518031569ELM HP PTA 9mm x 40mm x 40cm
05391518031552ELM HP PTA 8mm x 80mm x 40cm
05391518031545ELM HP PTA 8mm x 60mm x 40cm
05391518031538ELM HP PTA 8mm x 40mm x 40cm
05391518031521ELM HP PTA 8mm x 20mm x 40cm
05391518031514ELM HP PTA 7mm x 100mm x 40cm
05391518031507ELM HP PTA 7mm x 60mm x 40cm
05391518031491ELM HP PTA 7mm x 40mm x 40cm
05391518031484ELM HP PTA 7mm x 20mm x 40cm
05391518031477ELM HP PTA 6mm x 100mm x 40cm
05391518031460ELM HP PTA 6mm x 60mm x 40cm
05391518031453ELM HP PTA 6mm x 40mm x 40cm
05391518031446ELM HP PTA 6mm x 20mm x 40cm
05391518031439ELM HP PTA 5mm x 60mm x 40cm
05391518031422ELM HP PTA 5mm x 40mm x 40cm
05391518031415ELM HP PTA 5mm x 20mm x 40cm
05391518031408ELM HP PTA 4mm x 40mm x 40cm
05391518031392ELM HP PTA 4mm x 20mm x 40cm
05391518031385ELM HP PTA 3mm x 40mm x 40cm

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