Achilles NC PTA Balloon Dilatation Catheter 804-020100-090U

GUDID 06958481421088

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

Primary Device ID	06958481421088
NIH Device Record Key	7ade2bdb-e5e8-48bf-beea-6780fb76c0e8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Achilles NC PTA Balloon Dilatation Catheter
Version Model Number	rev 01
Catalog Number	804-020100-090U
Company DUNS	421318800
Company Name	BrosMed Medical Co.,Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958481421088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160941

FDA Product Code

LIT	Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-06-30

On-Brand Devices [Achilles NC PTA Balloon Dilatation Catheter]

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