ARZZT 02095401

GUDID B61502095401

TRUEMED GROUP, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B61502095401
• NIH Device Record Key: 934cc48c-c791-4327-a9c8-53e5eabc4088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARZZT
• Version Model Number: 02095401
• Catalog Number: 02095401
• Company DUNS: 004154534
• Company Name: TRUEMED GROUP, 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B61502095401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162507

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[B61502095401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-05-30

On-Brand Devices [ARZZT]

• B61503134101: 03134101
• B61502095406: CONICAL LOCKING SCREW 2.7 X 20MM FOR DISTAL $300.00 $300.00 RADIUS PLATE TITANIUM
• B61502095401: 02095401