Main-Mallet-Spinal Simplicity 35-0011-000

GUDID B908350011000

Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile

Mainstream Medical Devices, LLC

Surgical mallet

• Primary Device ID: B908350011000
• NIH Device Record Key: aadb433c-8229-41e0-923e-8d7e7350ac45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Main-Mallet-Spinal Simplicity
• Version Model Number: 316-35-911
• Catalog Number: 35-0011-000
• Company DUNS: 071513432
• Company Name: Mainstream Medical Devices, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com
• Phone: 512-289-3437
• Email: dana.wilcox@mainstreammedicaldevices.com

Device Dimensions

• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch
• Weight: 1 Pound
• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B908350011000 [Primary]

FDA Product Code

• HXL: Mallet

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: 2025-04-14
• Device Publish Date: 2025-04-04

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• B90831635080 - Main-Mallet: 2025-04-14 Single-Use, Mallet, 8" Slotted, Small Contoured Handle, 16oz Head Weight, Sterile
• B908350011000 - Main-Mallet-Spinal Simplicity: 2025-04-14Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile
• B908350011000 - Main-Mallet-Spinal Simplicity: 2025-04-14 Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile
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