Simplex 6197-9-001

GUDID 37613327128421

Tobra Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6197-9-010

Howmedica Osteonics Corp.

Orthopaedic cement, medicated

• Primary Device ID: 37613327128421
• NIH Device Record Key: 1f4f1529-3616-4d2b-b32f-4148052eba74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplex
• Version Model Number: 6197-9-001
• Catalog Number: 6197-9-001
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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 Dimensions

• Weight: 41 Gram
• Total Volume: 20 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327128420 [Primary]
GS1	37613327128421 [Package]; Contains: 07613327128420; Package: pack [10 Units]; In Commercial Distribution
GS1	57613327128425 [Package]; Package: case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014199

FDA Product Code

• LOD: BONE CEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-19

On-Brand Devices [Simplex]

• 37613327128452: SpeedSet Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6192-1-010
• 37613327128445: Full Dose Bone Cement, 10 pack catalog number is 6191-1-010
• 57613327128432: Half Dose Bone Cement, 10 pack catalog number is 6188-1-010
• 37613327128421: Tobra Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6197-9-010