Osseoflex® OT-0222/B

GUDID 10884450387396

Merit Medical Systems, Inc.

Inflatable bone tamp

• Primary Device ID: 10884450387396
• NIH Device Record Key: 70084d8e-9786-4118-9028-2be7386ee918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osseoflex®
• Version Model Number: 00884450387399
• Catalog Number: OT-0222/B
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450387399 [Primary]
GS1	10884450387396 [Package]; Contains: 00884450387399; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150607

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

On-Brand Devices [Osseoflex®]

• 00884450328491: 00884450328491
• 00884450328293: 00884450328293
• 00884450328286: 00884450328286
• 00884450328279: 00884450328279
• 00884450328262: 00884450328262
• 00884450328156: 00884450328156
• 00884450328149: 00884450328149
• 00884450328071: 00884450328071
• 00884450327975: 00884450327975
• 00884450327951: 00884450327951
• 00884450327944: 00884450327944
• 00884450327937: 00884450327937
• 00884450327920: 00884450327920
• 00884450327913: 00884450327913
• 00884450327906: 00884450327906
• 00884450327883: 00884450327883
• 00884450327876: 00884450327876
• 00884450327852: 00884450327852
• 00884450386842: 00884450386842
• 00884450387405: 00884450387405
• 10884450386757: 00884450386750
• 10884450386740: 00884450386743
• 00884450387436: 00884450387436
• 00884450386736: 00884450386736
• 10884450387396: 00884450387399
• 00884450387412: 00884450387412
• 10884450387426: 00884450387429
• 00884450386835: 00884450386835