Arcadia™ ARC15ST-LK

GUDID 00884450447208

Merit Medical Systems, Inc.

Inflatable bone tamp

• Primary Device ID: 00884450447208
• NIH Device Record Key: 4921f75d-e906-4b3e-8c24-1a9ea20cd6be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arcadia™
• Version Model Number: 00884450447208
• Catalog Number: ARC15ST-LK
• 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: true
• 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	00884450447208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191596

FDA Product Code

• HRX: Arthroscope

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: 2020-10-22
• Device Publish Date: 2020-10-14

On-Brand Devices [Arcadia™]

• 10884450447229: 00884450447222
• 10884450447168: 00884450447161
• 10884450447106: 00884450447109
• 10884450447373: 00884450447376
• 10884450447250: 00884450447253
• 10884450447342: 00884450447345
• 10884450447281: 00884450447284
• 00884450447352: 00884450447352
• 00884450447239: 00884450447239
• 10884450447199: 00884450447192
• 10884450476854: 00884450476857
• 10884450447311: 00884450447314
• 00884450462539: 00884450462539
• 10884450447137: 00884450447130
• 00884450447178: 00884450447178
• 10884450490881: 00884450490884
• 00884450447116: 00884450447116
• 10884450490898: 00884450490891
• 10884450490874: 00884450490877
• 00884450447291: 00884450447291
• 10884450490867: 00884450490860
• 10884450476861: 00884450476864
• 00884450447208: 00884450447208
• 00884450490846: 00884450490846
• 00884450490839: 00884450490839
• 00884450490914: 00884450490914
• 00884450547557: 00884450547557
• 00884450547533: 00884450547533
• 10884450490850: 00884450490853
• 00884450547519: 00884450547519
• 00884450447260: 00884450447260
• 00884450547502: 00884450547502
• 00884450547359: 00884450547359
• 00884450490907: 00884450490907
• 00884450547526: 00884450547526
• 00884450547540: 00884450547540
• 00884450462478: 00884450462478
• 00884450749517: 00884450749517
• 00884450749562: 00884450749562
• 00884450749524: 00884450749524
• 00884450748961: 00884450748961
• 00884450749579: 00884450749579
• 00884450749548: 00884450749548
• 00884450497524: 00884450497524
• 00884450490808: 00884450490808
• 00884450490792: 00884450490792
• 00884450490761: 00884450490761
• 00884450748978: 00884450748978
• 00884450780398: F
• 00884450780404: F