StabiliT® 1436-01/B

GUDID 10884450315924

Merit Medical Systems, Inc.

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 10884450315924
• NIH Device Record Key: b98dc11b-8ae4-49ae-8a36-c7336ec457eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabiliT®
• Version Model Number: 00884450315927
• Catalog Number: 1436-01/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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450315927 [Primary]
GS1	10884450315924 [Package]; Contains: 00884450315927; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072496

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-10

On-Brand Devices [StabiliT®]

• 10884450379858: 00884450379851
• 10884450379841: 00884450379844
• 10884450379834: 00884450379837
• 10884450379827: 00884450379820
• 00884450374344: 00884450374344
• 10884450325763: 00884450325766
• 10884450325701: 00884450325704
• 10884450325664: 00884450325667
• 10884450325640: 00884450325643
• 10884450325619: 00884450325612
• 10884450325602: 00884450325605
• 10884450317669: 00884450317662
• 10884450317652: 00884450317655
• 10884450317645: 00884450317648
• 10884450317638: 00884450317631
• 10884450315924: 00884450315927
• 10884450315917: 00884450315910
• 10884450315900: 00884450315903
• 10884450315894: 00884450315897
• 10884450314484: 00884450314487
• 10884450314316: 00884450314319
• 10884450296506: 00884450296509
• 10884450296469: 00884450296462
• 10884450296414: 00884450296417
• 10884450296308: 00884450296301
• 10884450296278: 00884450296271
• 10884450296247: 00884450296240
• 10884450296223: 00884450296226
• 10884450296216: 00884450296219
• 00884450374337: 00884450374337
• 10884450379902: 00884450379905
• 00884450314074: 00884450314074
• 10884450390457: 00884450390450
• 10884450413996: 00884450413999
• 00884450314081: 00884450314081
• 00884450469057: 00884450469057
• 10884450441456: 00884450441459
• 10884450390471: 00884450390474
• 10884450390464: 00884450390467
• 00884450469064: 00884450469064
• 10884450503338: 00884450503331
• 10884450390440: 00884450390443
• 10884450492366: 00884450492369
• 10884450296230: 00884450296233
• 00884450469088: 00884450469088
• 00884450492444: 00884450492444
• 00884450492437: 10884450492434
• 00884450492352: 10884450492359
• 00884450492420: 00884450492420
• 10884450492373: 00884450492376