TruTrack Memory Staple System

GUDID G0792001176310

Intelivation, LLC

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: G0792001176310
• NIH Device Record Key: bbb8b8b5-b877-4c36-b447-163f27e0bc1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruTrack Memory Staple System
• Version Model Number: 2001.17631
• Company DUNS: 037368183
• Company Name: Intelivation, LLC
• 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: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G0792001176310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [TruTrack Memory Staple System]

• G0792600010: 2600.01
• G0792001177530: 2001.17753
• G0792001177520: 2001.17752
• G0792001177510: 2001.17751
• G0792001177500: 2001.17750
• G0792001176540: 2001.17654
• G0792001176520: 2001.17652
• G0792001176510: 2001.17651
• G0792001176470: 2001.17647
• G0792001176380: 2001.17638
• G0792001176370: 2001.17637
• G0792001176360: 2001.17636
• G0792001176350: 2001.17635
• G0792001176340: 2001.17634
• G0792001176330: 2001.17633
• G0792001176320: 2001.17632
• G0792001176310: 2001.17631
• G0792001176300: 2001.17630
• G0792001176290: 2001.17629
• G0792001176280: 2001.17628
• G0792001176270: 2001.17627
• G0792001176260: 2001.17626
• G0792001176250: 2001.17625
• G0792001176240: 2001.17624
• G0792001176230: 2001.17623
• G0792001176220: 2001.17622
• G0792001060: 2001.06
• G0792001050: 2001.05
• G0792001040: 2001.04
• G0792001030: 2001.03
• G0792001020: 2001.02
• G0792001010: 2001.01
• G0792001176620: 2001.17662
• G0792001176610: 2001.17661
• G0792001176600: 2001.17660
• G0792001176590: 2001.17659
• G0792001176530: 2001.17653
• G0792001227750: TruTrack MEMORY STAPLE 15X15-1.5X1.5MM PKG
• G0792001227740: TruTrack MEMORY STAPLE 13X15-1.5X1.5MM PKG
• G0792001177820: TruTrack MEMORY STAPLE 9X9-1.5X1.5MM PKG
• G0792001177810: TruTrack MEMORY STAPLE 7X7-1.5X1.5MM PKG