Isto Disposable Awl 7.5/8.0 Anchor IFLX-DA-7580

GUDID B90839940758311

Disposable Awl 7.5/8.0 Anchor

Mainstream Medical Devices, LLC

Bone awl, single-use

• Primary Device ID: B90839940758311
• NIH Device Record Key: 502cb3e9-08a4-49dc-b976-90eb53453253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isto Disposable Awl 7.5/8.0 Anchor
• Version Model Number: 399-40-758-311
• Catalog Number: IFLX-DA-7580
• 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: false
• 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
HIBCC	B90839940758311 [Primary]

FDA Product Code

• HWJ: Awl

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by Mainstream Medical Devices, LLC

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• B90831225080 - Main-Mallet: 2025-04-14 Single-Use, Mallet, 8" Small Contoured Handle, 12oz Head Weight, Sterile
• B90831625080 - Main-Mallet: 2025-04-14 Single-Use, Mallet, 8" Small Contoured Handle, 16oz Head Weight, Sterile
• B90831635080 - Main-Mallet: 2025-04-14 Single-Use, Mallet, 8" Slotted, Small Contoured Handle, 16oz Head Weight, Sterile
• B908350011000 - Main-Mallet-Spinal Simplicity: 2025-04-14 Single-Use, Surgical Mallet, Slotted, 8" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile
• B908350008000 - Main-AXS Needle-Spinal Simplicity: 2024-12-11 Single Use, Bone Access Needle, Sterile Blunt Stylus & Blunt Cannula with Extra Trocar Stylus
• B908350009000 - Main-AXS Needle-Spinal Simplicity: 2024-12-11 Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula
• B90831020150 - Sterile Drill Bit: 2024-08-19 Single-Use, Non-cannulated Drill, Sterile