KyphoFlex™ KPA20A

GUDID 10884450845315

Merit Medical Systems, Inc.

Inflatable bone tamp

Primary Device ID	10884450845315
NIH Device Record Key	400cba3d-eda8-4eb5-aae4-7b04bfb4c8e8
Commercial Distribution Status	In Commercial Distribution
Brand Name	KyphoFlex™
Version Model Number	Initial Release
Catalog Number	KPA20A
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
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	true
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	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450845318 [Primary]
GS1	10884450845315 [Package] Contains: 00884450845318 Package: [15 Units] In Commercial Distribution

FDA Product Code

HRX	Arthroscope

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-11-04
Device Publish Date	2024-10-25

On-Brand Devices [KyphoFlex™]

00884450847046	Initial Release
10884450845322	Initial Release
10884450845315	Initial Release
10884450845308	Initial Release

Trademark Results [KyphoFlex]

Mark Image Registration \| Serial	Company Trademark Application Date
KYPHOFLEX 98524369 not registered Live/Pending	MEDTRONIC HOLDING COMPANY SARL 2024-04-29