4.5mm Smooth Washer

GUDID 00812926029580

TRILLIANT SURGICAL, LTD.

Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

• Primary Device ID: 00812926029580
• NIH Device Record Key: 1a91a4d0-9307-4c8b-b7e5-caeb7c7300d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.5mm Smooth Washer
• Version Model Number: 200-45-001
• Company DUNS: 828829072
• Company Name: TRILLIANT SURGICAL, LTD.
• 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: 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
GS1	00812926029580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153338

FDA Product Code

• NDG: Washer, Bolt, Nut, Non-Spinal, Metallic

Sterilization

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

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

[00812926029580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-23
• Device Publish Date: 2019-08-15

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• 00810028391536 - Arsenal Petite MPJ Plate, L, 5°: 2021-09-13
• 00810028391543 - Arsenal Petite MPJ Plate, R, 5°: 2021-09-13
• 00810028391550 - Arsenal Short 5th Met Hook Plate, L: 2021-09-13
• 00810028391567 - Arsenal Short 5th Met Hook Plate, R: 2021-09-13
• 00810028391574 - Arsenal U-Plate, Small, L: 2021-09-13
• 00810028391581 - Arsenal U-Plate, Small, R: 2021-09-13